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Simcere Global Talents Recruitment

No. Function Position Location
1 Simcere R&D VP of Innovation R&D Center (Head of Shanghai Innovation Center) Shanghai,China
2 Simcere R&D VP of Innovative Drug R&D (Head of Boston Innovation Center) Boston
3 Simcere R&D VP of Biopharmaceutical R&D Nanjing,China
4 Simcere R&D VP of Small Molecule Innovative Drug R&D Shanghai,China
5 BD VP of International BD Shanghai,China
6 Simcere R&D Formulation Development Director/Senior Director Nanjing,China
7 Simcere R&D Process Chemistry Research & Development Director/Senior Director Nanjing,China
8 Simcere R&D Head of Quality and Compliance (Senior Director) Nanjing,China
9 Simcere R&D Senior Manager/Assistant Director of Bio-IP Nanjing,China/Beijing,China
10 Simcere R&D Project Management Manager/Senior Manager/Assistant Director Nanjing,China
11 Simcere R&D CMC Regulatory Strategy Research Senior Manager / Deputy Director Nanjing,China
12 Simcere R&D Director (Senior Director)of Cancer Discovery and Biological Immunopharmacology Shanghai,China
13 Simcere R&D DMPK Director (Senior Director) Shanghai,China
14 Simcere R&D Toxicology Director (Senior Director) Shanghai,China
15 Simcere R&D Pharmaceutical Chemistry Director/Senior Director Shanghai,China
16 Simcere R&D Director or Senior Director of Assay Development Shanghai,China
17 Simcere R&D Clinical Operations Director (Senior Director) Shanghai,China、Nanjing,China
18 Simcere R&D Clinical Science Associate Director/Director/Senior Director (Tumor or Immunity) Shanghai,China、Nanjing,China
19 Simcere R&D Clinical Science Director (Senior Director) (Nervous System Direction) Shanghai,China、Nanjing,China
20 Simcere R&D Clinical Pharmacology Director/Deputy Director (Generics) Nanjing,China
21 Simcere R&D Clinical Pharmacology Director/Deputy Director (innovative drug) Shanghai,China
22 Simcere R&D Senior Director of Statistics/Director/Deputy Director Shanghai,China
23 Simcere R&D DM Senior Director/Director/Deputy Director Shanghai,China
24 Simcere R&D Head, Pharmacovigilance & Drug Safety (Director or Senior Director) Shanghai,China、Nanjing,China
25 Simcere R&D Director/Senior Director, Bioinformatics Shanghai,China、Nanjing,China
26 Simcere R&D Director/Senior Director, Cell Science Shanghai,China、Nanjing,China
27 Simcere R&D Antibody Engineering Director (Senior Director) Shanghai,China、Nanjing,China
28 Simcere R&D In Vivo Pharmacology Director (Senior Director) Shanghai,China、Nanjing,China
29 Simcere R&D In Vitro Pharmacology Director (Senior Director) Shanghai,China、Nanjing,China
30 Simcere R&D Biomedicine CMC Senior/Executive Director Nanjing,China
31 Simcere R&D Regulatory CMC Project Lead Shanghai,China
32 BD BD Director / Associate Director (Innovative Drugs) Shanghai,China、Nanjing,China
33 BD BD Director / Deputy Director (Generics) Shanghai,China、Nanjing,China
34 BD BD Director (Investment Development Department) Shanghai,China、Nanjing,China
35 BD BD Director Japan
36 BD BD Director Europe
37 BD Scientific Assessment Director Europe
38 BD BD Senior Director/Director USA
39 BD Domestic BD Director/Senior Director Nanjing,China
40 Simcere Manufacturing Group Production Operations (Assistant Director/Director) Nanjing,China
41 Simcere Manufacturing Formulating Chief Engineer/Senior Engineer Haikou,China
42 Simcere Manufacturing International Pharmaceuticals Senior Director/Director/Deputy Director USA
43 Simcere Manufacturing Senior Director/Director/Deputy Director of International Sales Nanjing,China
44 Simcere Manufacturing Senior Director/Director of Supply Chain Management Nanjing,China
45 Simcere Manufacturing VP of International Pharmaceuticals Nanjing,China
46 Headquarters Strategic Development Director Nanjing,China

 

Please submit your resume to Global Recruitment: [email protected]

Life Sciences Future 2018

As part of our partnership, Life Sciences PA has offered a steeply discounted rate of $525, which is a $200 discount off the regular registration price for SAPA-GP members and friends to attend their annual fall conference, Life Sciences Future, being held at the Pennsylvania Convention Center on October 29-30. Life Sciences PA sincerely invites everyone to attend and experience the many features this conference has to offer. You can learn more about Life Sciences Future. To register for Life Sciences PA’s fall conference and take advantage of the discount, please use this link to register as a SAPA-GP member.

Immuno-Oncology 2.0, Philadelphia Pharmaceutical Symposium 2018

December 8th, 2018

Crowne Plaza, King of Prussia, PA

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December 8th, 2018

Crowne Plaza, 260 Mall Blvd Vichit, King of Prussia.

 

Continuing last year's theme, the 2018 Philadelphia Pharmaceutical Symposium is titled "Immuno-Oncology 2.0" and will focus on breakthrough in Immuno-Oncology therapy and emerging new platforms.

Join the vibrant Immuno-Oncology R&D community and exchange ideas with experts from academia and industry. Register Now! Early-Bird Registration will end on Nov 9th.

 

Featured Speakers:

  • Carl June, MD. Perelman School of Medicine, University of Pennsylvania
  • Katrin Rupalla, PhD, MBA. Head of Oncology Development Global Regulatory Science, BMS
  • Scot Ebbinghaus, MD. Vice President and Therapeutic Area Head, Oncology Clinical Research, Merck & Co.
  • Michael Kalos, PhD. Vice President of Immuno-Oncology, Janssen R&D
  • Jean-Pierre Issa, MD. Lewis Katz School of Medicine, Temple University
  • Liang Deng, MD, PhD. Physician Scientist, Associate Member Memorial Sloan Kettering Cancer Canter

Agenda

Morning Theme

Breakthrough Immuno-Oncology Therapies

Afternoon Theme

Emerging New Immuno-Oncology Platforms

 

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2018 Career Development Workshop For Students and PostDocs

September 22nd, 2018, University of Pennsylvania, Philadelphia, PA

SAPA-GP held its annual Student Career Development Workshop. The goal of the workshop was to teach students networking and interviewing skills and also to give them ideas on the many career opportunities in life sciences.  The workshop included 5 speeches and 6 breakout sessions. We were honored to have 19 distinguished speakers from pharmaceutical companies, contract research organizations, law firms and consulting firms. They provided their insights on the many diverse work opportunities that graduate students and postdoctoral fellows can pursue after graduation. The event was well-received by the community, and tickets were sold out well ahead of the deadline. During the event, we saw heated one-on-one discussion between attendees and speakers, and all our attendees returned with fruitful results and provided very positive feedback.

 

Keynote speeches

 

Overview of job opportunities in pharma

We were honored to have Dr. Jim Wang, Head of Regulatory Affairs at Spark Therapeutics, Inc., to kick off the workshop by giving an overview of diverse job opportunities in pharma and biotech. First, he covered the drug discovery and development process and what type of expertise and teams are needed to support each stage. He elaborated on career paths such as project management, biostatistics, medical affairs, regulatory affairs, process development & CMC, market access, legal and patent law. He finished by using his own career journey to encourage the audience to keep an open mind, and embrace various opportunities and different career paths in the future.

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Current visa issues

Ms. Valentine A. Brown, JD, Partner of Duane Morris LLP discussed what kind of visa applications international students may be eligible after graduation, including H1B and Green Card application, and how one should prepare for them. Ms. Brown said, even though the new policies are less friendly, one can still succeed as long as we prepare well. Later in the afternoon breakout session, Ms. Brown provided one-on-one help for attendees who had more visa questions.

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How resumes are screened by HR

The CEO of GTS Recruiting, Robb Hoyle gave a speech about “How resumes are screened by HR & Key Resume Issues”. During his speech, he explained the differences of the HR screening process in large Pharma and small biotech companies. He also provided great suggestions about good resumes writing and mistakes to be avoided when preparing a resume. In the end, he mentioned the importance of LinkedIn in job searching and how to effectively manage the LinkedIn profile.

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How to read a job description

Larry Petcovic, who is the co-founder of SciPhd.com, showcased how todecipher a job description and create a tailored resume. The question "How to read a job description?" might sound naive, but we would never have thought of the necessity to tailor a different resume for every job posting. Larry focused on how to create the best resume each time based on the what the job posting was targeting for. He used a job advertisement example from LinkedIn to help us understand the process of mapping a job advertisement to identify our critical competencies such as business and operational competencies. Then Larry went into details about how to dissect the job posting and look for key terms to include in ones’ targeted resume.

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High impact communication, networking, and American culture

Dr. David Cragin, Associate director of Chemical Notifications and Registration at Merck & Co. used real life examples of how networking helped students he met in SAPA events landed on great jobs to show the importance of networking. Then he provided practical tips for building your network, such as how to prepare for a 10-second “elevator speech”, dress professionally, and understand American culture. He also showed examples on how to follow up with connections effectively through emails and LinkedIn. In the end, he encouraged students to join SAPA-GP as a volunteer, which can help grow your network and build your career.

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Breakout Sessions

 

Tips for job hunting: resume, interview, and negotiation

In the breakout session, Mr. Larry Petcovic and Dr. David Cragin spoke about “Tips for job hunting: resume, interview, and negotiation”. Larry suggested that the resume should be clear and specific, avoiding exaggeratiion. Dr. Cragin suggested that the presentation at the interview should be easy to understand and it was important to pay attention to the interviewers’ reaction and adjust the answer accordingly.

 

Alternative career paths: Business Development & Consulting

Many attendees with scientific background are very interested in potential alternative career paths. We are glad to have Mr. Guangyao Yang, Dr. Ling Liu, and Dr. Steve Wu to share their work experiences in business development and consulting. Speakers enthusiastically answered attendees’ questions such as how they should prepare for such positions, what kind of qualifications they should meet for these positions in comparison with science and technology based positions, and which traits of the future employees those companies will value most. The panelists discussed all questions and gave very practical suggestions.

 

Alternative career paths: Regulatory affairs & Scientific writing

The panelists included Dr. Hui Wang  (Associate Manager at Regeneron Pharmaceuticals, Inc.), Dr. Yue Liu (Assistant Scientific Director at Chameleon Communications International), Dr. Xianhua Li ( Project Manager intern at DataRevive LLC)  and Ms. Shirley Ruan (Project Manager at Aleon Pharma International, Inc.). The panelists first gave a brief introduction to this field and shared their daily work such as their responsibility and what their work-life balance is like.  Since many participants come from the background of research scientist and did not know much about this field, this was very helpful. Some of the participants even consider swtiching from lab work to regulatory affairs. Accordingly, the panelists introduced the relevant preparation such as the training course and certification. In addition, they shared their own valuable experience of how they started job hunting.

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Working for CRO or pharma & Working in China or the US

The President of Alliance Pharma Frank Li, the Associate Scientific Director of The Janssen Pharmaceutical Companies of Johhson & Johnson Songmao Zheng and the Market Research Manager of Hisun Pharmaceuticals Liping Xing were invited to the breakout session “Working for CRO or pharma & Working in China or the US” to share their experience and suggestions. They said regardless of pursuing a career path at a CRO or traditional pharma, the solid working capability is always the first thing that matters most. They also mentioned the pharmaceutical industry has been developing rapidly in China nowadays, so it is also a good choice to go back China and build a career there.

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Interviewing skills and mock interviews

In the breakout session of "interviewing skills and mock interviews", Dr. Jing Yang (Senior Principal Scientist at Bristol-Myers Squibb) and Dr. Dennis M. Gross (CEO & Treasurer of the Pennsylvania Drug Discovery Institute) shared ways to manage stress and how to prepare for interviews. Preparation involves taking an inventory of experiences and the consideration of experience that go beyond the resume. In addition, they demonstrated that you need to change your interviewing style based on the employers’ style of interviewing.  Furthermore, they provided online resources and virtual mock interview software that can be helpful for interview preparation.

 

 

 

 

 

Reporters: Liangqiu Li, Xianhua Li, Lin Zeng, Qiangnan Zhang

Editors: David Cragin, Han Dai

 

AcroBio Biosystems, multiple positions

PositionApplication Support Manager

Report LineUS Commercial Team Head

LocationBoston / Delaware

Responsibilities

  • Provide technical support for the product lines and services by answering customer technical inquiries. Inquiries may be received via telephone, email or web chat.
  • Provide customer support on technical issues by utilizing all available resources and escalate issues or problems when warranted.
  • Participate in frequent training on products and continuing education on new applications and technologies to remain at the cutting edge of scientific knowledge.
  • Accurately record pertinent information from customer contacts in Customer Relationship Management system.
  • Summarize trends and technology as technical tips, FAQ’s and troubleshooting guides.
  • Recommend changes to knowledge databases, website, and other company-managed databases of technical information.
  • Present technical updates to colleagues and contribute to department meetings.
  • May present technical and product information at trade shows and in customer field visits.
  • Participate in additional special team or individual projects.
  • Lead product trainings for internal employees
  • May be required to perform other related duties as opportunities arise

Requirements:

Experience

·         Requires a M.S. or Above degree in Immunology, Protein Chemistry or similar field.

·         Preferred Qualifications: A PhD. or a PhD. with post-doctoral experience.

·         5+ years of laboratory experience in Immunoassay, or protein chemistry or other bioassay techniques required.

·         Experience in an applied science area (i.e. antibody development, clinical research, ,diagnostics, etc) a plus

Professional Knowledge

·         Proven technical writing capabilities

·         Presentation skills

·         Proven ability to quickly learn large amounts of new, complex technical information

·         Demonstrated ability to effectively communicate, both orally and in writing, to customers and colleagues

·         Ability to manage multiple priorities

·         Problem-solving ability

·         Computer literacy, including spreadsheet, database, word processing and Internet applications

·         Prior experience in customer service is desirable

 

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PositionLab Operation Director

Report LinePresident/CEO

LocationDelaware

Responsibilities

  • Leads and manages all operational functions involved in the production in alignment with business unit, divisional strategic and annual operating plans.
  • Ensures that projects are completed within assigned budget targets and timelines are met or exceeded.
  • Meets customer satisfaction objectives in the areas of order communication, on-time delivery, and installation as well as ongoing quality and reliability standards
  • Reduce the risk and costs of overall projects by carefully analyzing the needs at the outset, by identifying risk factors, and providing mitigation strategies. Identified issues are to be addressed with the customer early in the project in a collaborative approach.
  • Drives continuous improvement and productivity
  • Leads the Operation to high levels of Operational Excellence, productivity, and inventory turnover through contemporary Lean Manufacturing and Supply Chain Management concepts
  • Drives improvement in material costs through value engineering, supply base consolidation, and Low Cost Region sourcing
  • Ensures the Operations Organization is a key participant and stakeholder in the New Product Development process, with the goal of development and on-time launch of high quality products that meet cost, feature, and quality objectives.
  • Drives a strong safety culture and maintains EH&S policies and GMP&GLP procedures for the site
  • Schedule testing to meet department and plant commitments.
  • Troubleshoot test procedures and/or equipment when problems arise.
  • Evaluate analytical results and determine conformance to specification; must be able to detect deviations and out of specifications events.
  • Maintain instrumentation/equipment in accordance with manufacturer’s labeling and in-house audit and calibration procedures.
  • Maintain working laboratory inventory, records and logs in accordance with procedures and GMP&GLP.
  • Assist in training laboratory personnel on lab procedures and operations of instrumentation and equipment.
  • Other laboratory functions as deemed necessary to support the business needs of the Company
  • Being technical support for MSD instrument production and QC (Quality Control) testing processes

Requirements:

Experience:

·         5+Experiences in one or more of the following: Immunology, Protein Chemistry or similar field.

·         Ability to organize work effectively to meet scheduling commitments.

·         Ability to troubleshoot problems with limited assistance.

·         Must be flexible and able to work overtime

·         Ability to interact with all departments and occasional contact with outside sources

·         Knowledge of GMP GLP and ISO requirements

·         Microsoft Office (Word and Excel) required.

 

Professional Knowledge

·         Doctors degree in business, operations, or a scientific field. An advanced degree in business or science is preferred.

·         8+ years of lab industry experience, preferably in portfolio management.

·         Knowledge of laboratory products and applications, actual working laboratory experience, or understanding of customer requirements in laboratory settings.

·         Sales, marketing, or other commercial functional knowledge.

·         Strong project management skills

·         Excellent interpersonal, customer orientation, presentation, and problem solving skills.

·         Must demonstrate leadership and strong relationship management and negotiation skills.

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PositionPrinciple Scientist

Report LineVPCRO Project

LocationBeijing Economic-Technological Development Area

Responsibilities

  • Assist VP of CRO Project to supervise the operation of the department, including hiring and training scientific staffs, setting up SOP for GLP facility and assure GLP compliance. Work with VP of CRO Project to meet the growth and needs of the company, responsible for training PIs and analysts within group, in both technical and compliance aspects;
  • Establish and maintain business relationship with worldwide companies. Develop and maintain high level of scientific achievements for the company. Be expected to be point of contact for project coordination, including email and video/tele- conference with customers;
  • Lead team to analyse large molecule samples from preclinical or clinical studies using immunoassays. Troubleshoot and provide ongoing advice to team members as needed. Draft study reports, including assay development report, validation report sample analysis report, etc
  • Be required to effectively communicate and interface with business partners, internal Quality Assurance Unit and external regulatory authorities in order to fully comply with GLP regulations;
  • Prepare, review or approval internal method development, validation and bioanalytical reports and present data to project team and management

Requirements:

Experience

·         Experience with immunological techniques such as ELISA. Knowledge and/or experience with biologics pharmacokinetics (PK) assays and immunogenicity assays;

·         Experience with writing/reviewing study reports and contributing to regulatory submissions;

·         MS or PhD in biochemistry, biology, Pharmacology or related field, with 3-5 years working experience.

Professional Knowledge

·         Excellent communication and inter personal skills;

·         Ability to effectively prioritize and execute tasks in a high-pressure environment;

·         Strong working knowledge of Microsoft Office, Microsoft Project in particular.

 

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PositionProject Manager

Report LineVPCRO Project

LocationBeijing Economic-Technological Development Area

Responsibilities

  • Monitor and assist project teams with multiple parallel projects;
  • Coordinate resources across multiple departments and multiple groups;
  • Guide Clients to understand project scope while limiting “mission-creep”;
  • Act as the point of contact for Clients on assigned studies;
  • Work with scientific personnel to develop a schedule for project completion that effectively allocates the resources to the activities;
  • Establish a communication schedule to update stakeholders;
  • Conduct kick-off meeting with stakeholders to assign duties/roles and set timelines;
  • Author and deliver meeting minutes, progress reports and other ad hoc documents.

Requirements:

Experience

·          Successful candidates will possess an advanced degree in a relevant scientific discipline;

·          Master’s Degree plus ≥ 2 years relevant industry experience or 1-year CRO experience;

·         Bachelor’s Degree plus ≥ 5 years relevant industry experience or 5-year CRO experience.

Professional Knowledge

·          Solid organizational skills including attention to detail and ability to juggle multiple priorities

·         Excellent client-facing and internal communication skills

·         Ability to effectively prioritize and execute tasks in a high-pressure environment

·         Strong working knowledge of Microsoft Office, Microsoft Project in particular

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PositionR&D Director

Report LinePresident/CEO

LocationBeiJing

Responsibilities

  • Lead the product development activities in the business unit, from concept through studies, and commercialization
  • Translate business unit strategy into actionable R&D plans and manage the product portfolio to best meet strategic priorities.
  • Liaise closely with marketing, product life cycle management, platform R&D, program management and program scientific leadership, to plan and implement timely development and introduction of high quality new products
  • Drive the implementation of product changes to optimize product performance, quality and reliability, production efficiency and effectiveness
  • Ensure quality systems and product development processes are effectively maintained and in compliance with internal and external quality and regulatory requirements
  • Develop and maintain a climate of creativity, initiative and innovation in the R&D teams
  • Strengthen the R&D organization to grow the capability to effectively execute demanding development projects in selected areas of focus
  • Develop R&D budgets and staffing requirements consistent with business unit objectives; assure maximum utilization and efficiency of all resources. Assemble, analyze and present R&D monthly financial and resource utilization metrics to senior leadership and follow-up upon request
  • Lead efforts to promote the best environment for and utilization of assigned department members, including recruiting, training, professional development and performance management

 

Requirements:

Experiences:

·         PhD in Life Science and a minimum of 10+ years of Senior level management experience within the life science and clinical diagnostic industry, specifically Immunology, Protein Chemistry or similar field.

·         Strong team leadership and group management skills.

·         Proven global Protein Chemistry experience

·         Ability to leverage the R&D portfolio against strategy and lead the right product roadmap

·         Must be a good team builder who can effectively and efficiently grow the organization to meet business goals

·         A partnering, consultative and open manner is key to success in this role.

·         Immunology, Protein Chemistry or similar field background preferred

 

Professional Knowledge

·         Minimum 10 years of experience in Protein production development, preferably in an international, inter-disciplinary environment. At least 5 years in a leadership role

·         Proven track record for effectively driving large scale development initiatives and working effectively in highly matrixed, global organizations

·         Strong business acumen and demonstrated leadership qualities, reflecting Thermo Fisher values, i.e., innovation, integrity, involvement and intensity

·         Demonstrated skills in project management and a track record of driving execution and creating a high performance working environment

·         Experience in intellectual property, invention disclosure and filing management

·         Strong interpersonal skills; able to interface & influence effectively

·         Ability to lead product development activites in a manner that develops individuals and promotes teamwork

·         Effective, articulate and concise communication - written, verbal and presentation skills. Ability to communicate effectively and comfortably with all organizational levels

 

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PositionSales Director

Report LinePresident/CEO

LocationBoston / Delaware

Responsibilities

  • Provide strong strategic and commercial leadership to the sales specialists to ensure profitable growth and share gain
  • Build strong collaborative working relationships with the business leaders and counter-parts in all ACRO commercial channels including corporate accounts
  • Establish the sales, solutions development and implementation process including: strategy, deal reviews and implementation project plans and goals
  • Work in close collaboration with Business Unit and Corporate functional teams in a matrix environment (marketing, key account management, financial shared services, IT, human resources)
  • Working effectively with Marketing and Product Development on sales, marketing and product management plans and services organization on implementations and on selling and servicing support contracts
  • Occasionally acting as a “player-coach” to close large, strategic deals for team of 3-5 territory managers across the US
  • Ensure the sales team meets established goal tree items in the areas of bookings and revenue growth, profitability, expense control, free cash flow, process optimization, productivity, employee development, and customer satisfaction
  • Manage inside sales team and managers to formulate effective strategies and processes for installed base expansion, aftermarket service growth and lead generation
  • Produce and deliver the AOP for the commercial operations in line with agreed upon goals including establishment and control of expense budgets
  • Focus on key/strategic customers to ensure the division achieves targeted growth objectives at all assigned strategic locations
  • Develop and foster relationships to ensure continued program sponsorship through strategic account management and business changes
  • Work with Business Development Project Managers to develop and approve solutions and pricing strategies
  • Work with your team to establish formal mechanisms and communications for providing insightful feedback on customer trends and requirements for new service/product development
  • Devise and implement consistent services salary and incentive plans in conjunction with the Commercial leader, the Human Resources team as well as drive the Human Resource Review process along with the annual Performance Management (PMD) & talent calibration processes
  • Establish processes, communications and collaboration with the services inside sales organizations to ensure alignment of account strategies and early identification of expansion opportunities

Requirements:

Experiences:

·         Strong leadership track record, which includes managing within a matrix environment along with the ability to inspire and lead others

·         10+Experiences selling protein or some related product to markets, such as pharmaceutical industry

·         Laboratory experience preferred

·         Superior track record of achieving and exceeding aggressive sales goals

·         Strong leadership skills, particularly driving change in a complex, worldwide

organization

·         Experience and knowledge of services business solutions

·         Familiarity with commercial operations and marketing tools to capture

 

Professional Knowledge

·         Ability to generate and maintain information to provide feedback on performance along with strong coaching and employee development skills

·         Effective negotiating and influencing skills

·         Ability to develop high levels of credibility and forge solid and positive professional relationships with customers, peers, and executive management

·         Exceptional knowledge and skill selling large productions to Global 500 companies and the ability to coach others to be effective key account managers

·         Demonstrate ACRO values

·         Reflector style – able to learn from mistakes and always wants to achieve best possible performance

·         Excellent communication skills, both written and oral

·         Ability to build and maintain processes and procedures while planning and prioritizing multiple tasks and projects

·         Completer with resilience to ensure a desirable outcome is always achieved

·         Advanced PC skills, especially in Microsoft Office products

 

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PositionVP/DirectorCRO Project

Report LinePresident/CEO

LocationBeijing Economic-Technological Development Area

Responsibilities

  • Lead a team of Bioanalytical scientists in immunoassay area to provide GLP-compliant service to work-class pharma and biopharma.
  • Interact with clients in planning new projects and test procedures. Supervise laboratory staff. Draft study proposals and quotations in response to client requests
  • Maintain good relationship with clients, make sure deliver data and report on time with good quality; Communicate project timelines, status, and data to Principle Investigator effectively addressing any issues that may arise;
  • Supervise all projects to ensure compliance with GLP and other guidelines related to bioanalytical study and to satisfy client’s quality requirements;
  • Participate the activities in the improvement quality and efficiency of CRO groups. Provide technical guidance and assay troubleshooting to the team, develop new technologies to maintain high level of scientific achievement for the company.
  • Is responsible for allocation of bioanalytical resources to ensure assay timeline;
  • Be responsible for performance management, recruitment, talent management, people/career development, people retention

Requirements:

Experience

·         Ph.D. in pharmaceutical sciences, immunology, biology or a related field

·         Years of experience at least 5 years of industrial GLP bioanalytical experience, ideally within pharma and biotech, with at least 2 years of experience of managing skilled professional staff

·         Familiar with pharmaceutical R&D process

·         Hands-on experience on immunoassay development, validation, and sample analysis.

Professional Knowledge

·         Must be familiar with GLP regulations

·         Be able to initiate innovative research in bioanalysis areas;

·         Good organizational and communicational skills

·         Proven ability of managing & developing people

·         Good interpersonal communication skills; excellent oral and written English

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ACROBiosystems is a leading manufacturer of recombinant proteins. We provide high quality protein reagents to the pharmaceutical research community. ACROBiosystems currently has an open position of Customer Service Specialist at its San Jose site.

Job Summary :

The Customer Service Specialist ensures that all customer needs are promptly addressed by responding to customers’ requests, orders, questions and concerns in a timely and accurate manner, while exercising the highest level of service and quality.

Qualified candidates for this position must have a passion for excellence, outstanding communication and organizational skills, as well as the ability to readily build relationships over the phone. Additionally, a qualified candidate must be quality focused, an effective team player and be motivated to achieve a rewarding career within the organization.

Essential Position Responsibilities:

  • Receive inbound calls and respond to calls as appropriate
  • Take care of online chat system during designated hours
  • Promptly resolve customer service issues to the customer’s satisfaction per company procedures and standards
  • Create and maintain customer accounts in database
  • Perform administrative duties, reports and special projects associated with Customer Support
  • Perform other duties as assigned.

Additional Requirements:

  • Bachelor degree in business administration or related field or equivalent combination of education and experience.
  • Impeccable attention to detail with strong organizational skills
  • Exceptional communication skills and professional presence
  • Innovative problem solver, results minded and solution focused
  • Effective team player with the ability to work independently
  • Strong keyboarding skills
  • Proficient in MS Office

Job Location:

San Jose, California, United States

Position Type

Full-Time/Regular

 

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ACROBiosystems is an internationally recognized research reagent manufacturer. The company focuses on providing research reagents and solutions to pharmaceutical companies. ACROBiosystems has research facilities and offices in both the United States and in China, and currently has open position of Technical Support Scientist/Application Scientist in Wilmington Delaware.

Job Summary:

The individual will represent the technical arm of the sales and BD team. The primary responsibility will be providing timely technical support to the customers in North America and Europe. The main customers are research scientists from pharmaceutical companies, biotech companies, CROs, clinical laboratories, and academic labs.

The position is responsible for providing technical support, ranging from answering basic product-related questions to offering comprehensive tech solution. The position will be playing an important role in building and maintaining customer relationship.

The position will routinely work with the laboratory team members and the product managers to build better products/solutions for the clients.

Essential Position Responsibilities:

  • Provide timely support to the customers through email, phone calls, and visits.
  • Work closely with the sales team and the product team to identify customer need and sales opportunities.
  • Work with the sales team and the CS team to improve overall customer experience.
  • Work with the laboratory members to develop better solutions for service customers.
  • Attend tradeshows, both local and international, and networking events as necessary.
  • Ability to travel within the territory 10% of the time.

Additional Requirements:

  • A Ph. D. degree of biomedical disciplines from an US research institution is required.
  • Have a good understanding of the current landscape of biologic drug discovery and relevant technologies.
  • Relevant working experience is preferred but not required.
  • Willingness to learn new technologies.
  • Ability to work independently.
  • Strong Communication Skills.

Job Location:

       Wilmington, Delaware

Rockland Announces General Release of BioQuantiPro™ Host Cell Protein Screening Kit for Bioprocessing

Limerick, PA. September 4, 2018 – Rockland Immunochemicals, Inc. announced today the general release of their new BioQuantiPro™ CHO-HCP ELISA Kit for detection and screening of host cell protein (HCP) contaminants in bioprocessing. The kit was specifically designed with Rockland’s novel, validated antibodies to detect HCP contaminants and to measure analytes from crude cellular harvests, cell culture lysates, and process intermediates. The BioQuantiPro CHO-HCP ELISA Kit boasts the highest coverage of generic CHO-HCP kits, low variability, and, most importantly, the data to back it all up.

“While working with bioprocessing clients, we consistently hear the same complaint about HCP kits: ‘The generic kit I am using works OK, but I wish I had reliable data that I can trust for the validation of the antibodies used in the kit’” commented Karin Abarca-Heidemann, PhD., Vice President of Science Operations. “We aimed to create a kit that fills the void by providing transparency into the data necessary to develop accurate bioprocessing standards with confidence. We are proud of what we have accomplished with this new kit and look forward to working with customers to advance the science of bioprocessing.”

Rockland has a long history of developing process-specific HCP antibodies in the biotherapeutics field. “Over the last 15 years we have successfully developed and manufactured custom process- specific HCP antibodies for our customers. In the design and function of this CHO-HCP kit, we drew upon our experience gained from working with a diverse set of biopharmaceutical clients. We are eager to see the feedback of the scientists who need this kit,” said David Chimento, PhD., Vice President of Client Solutions.

The BioQuantiPro CHO-HCP ELISA Kit is the first of several bioprocessing kits Rockland expects to release over the next eighteen months. Expect more and get more from Rockland in forthcoming kits for HEK 293 and Escherichia coli expression systems and other common bioprocessing contaminant targets.

# # #

Rockland Immunochemicals, Inc., (Rockland) provides the highest quality antibodies and antibody- based life science tools and services to the academic, biopharma, and diagnostic industries for use in basic research, assay development, preclinical and clinical studies, and bioprocessing. With facilities in Pennsylvania for over 55 years, Rockland manufactures products ideally suited for integration into critical assays such as western blotting, immunohistochemistry (IHC), immunofluorescence microscopy (IF), ELISA, flow cytometry, and 2D imaging. Additional information about Rockland’s life science tools and services can be found on Rockland’s website at www.rockland-inc.com.

Christina Rowley Marketing Communications Manager Rockland Immunochemicals, Inc. Phone: 484.791.3823 Email: [email protected]

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Wuxi Apptec, multiple positions, China & US

Company: WuXi Biologics

 

Department: AIS
Position:  AIS Site Director – 石家庄
Report to: Song Liu

 

Number:1

 

Location: 石家庄 site

 

Manager or Individual Contributor: Manager

 

Hiring manager: Song Liu On-board date: 2018.10
KEY ACCOUNTIBILITIES:

This is AIS site leader position to manage and supervise all AIS functions on site. (S)He will report to AIS Global Head, and dot line to VP, the Site Head, with key responsibilities as below.

 

[Global Role]
  • Visibly support and promote WuXi Biologics workplace safety, IP protection and GMP compliance
  • Key Member (or leader) of Global Technical Committees in subject matter of stainless steel – single user hybrid Maintenance Management, Process Automation or GMP IT Compliance.
  • Senior member of manufacturing global team, to instrument system standardization and operationalization at new manufacturing site following global strategy and alignment for GMP IT and Automation
  • Propose, analyze, and present new technology and project opportunity to Senior Management, support digital transformation initiatives such as Big Data, smart manufacturing
  • [Site Role]
  • Lead automation, instrumentation, mechanic and engineering support to highly automated manufacturing process, continue to improve system operability and reliability with a goal of achieving higher productivity
  • Govern computerized system life cycle management in accordance with validation strategy, data integrity guideline and established global /site SOPs.
  • Proactively sense and analyze the business change, work with different business stakeholders and supporting teams, ensuring smooth daily operation and compliance
  • Provide subject matter support for new system construction from URS to deployment, provide technical review and consultation for new facility design by enforcing QbD
  • Manage portfolio of AIS projects, establish value model to measure ROI, take accountability for project gate control and successful delivery.
  • Provide coaching, training to junior managers and engineers to improve team competency in technical, communication, compliance and sustainability

 

REQUIREMENTS:

  • Bachelor’s degree in Electric Engineering, Chemical Engineering, Mechanical Engineering, Industry Automation or related discipline is required with a minimum of 15 years of relevant experience
  • Minimum 8 years of experience with pharmaceutical manufacturing technology, total solutions offering and implementation. Experience with stainless steel system skids integration is a plus.
  • Minimum 5 years of experience in designing, implementing, operating, and troubleshooting of process analytical instrument, control elements, bioprocess equipment and process control
  • Must have strong customer service, coordination and interpersonal skills; must have cross-discipline team leading and personnel management experience
  • Track records of leading complex global project and system integration with great business result delivered
  • Good understanding on general computerized system, ERES regulation and compliance requirement for data integrity
EDUCATION (Indicate the mini. requirement & preferred discipline):

Bachelor or higher education degree

OTHER SKILLS, ABILITIES & EXPERIENCE:

 

  • Excellent interpersonal, communication, analytical, problem solving, troubleshooting and organizational skills
  • Self-motivated,quick paced with flexibility of working overtime to meet aggressive timeline
  • Good time management skill, resource planning
ADDITIONAL POSITION SPECIFIC DUTIES/INFO (Not Covered in Generic Description of Job):

 

 

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部门/班组:   上海质量保证部

Dept./Group:  QA-SH

岗位:   质量体系主任

Position:Assistant Director, Quality Systems

1.0      汇报范围Report Range
1.1              直接上级:QA 主任

Direct leader: QA Director

1.2              所属下级:文件管理员、档案管理员,培训专员

Subordinate: QA Specialists/Sr. QA specialists in Quality Systems (Document Management/Archives, Deviation/Change Control/CAPA, Metrics, Electronic systems management, Training management)

2.0      工作描述Job Description
2.1              遵守公司规章制度;

Obey the regulations of company;

2.2              管理下列上海GMP质量体系团队所支持的:

Manage the daily operations of the Quality systems functions in the areas of:

2.2.1      质量体系团队/职能的组建、维护和管理

Overall setup and management of Quality Systems group and functions

2.2.2      GMP操作相关的QA文件管理及归档

QA document control and document archives for GMP operations

2.2.3      定期质量回顾、文件回顾

Periodic quality metrics and document review,

2.2.4      GMP人员培训及公司年度培训计划的制订及管理

Development and maintenance of GMP training and company annual training plan;

2.2.5      变更、偏差和CAPA的管理

Change control, deviation and CAPA management;

2.2.6      电子系统的实施及管理

Electronic Systems Implementation and Maintenance for GMP operations

2.2.7      支持审计组进行内外部审计及跟踪活动

Assistance in audits/inspections for internal audit, external audits (client/regulatory agencies), and follow-ups;

2.3              监督上海GMP质量体系团队达成部门及公司的既定目标

Provide supervision to the Quality systems group to achieve defined department and corporate goals

2.4              代表QA参与CMC项目并直接与客户沟通QA、质量方面的问题与更新。

Act as a QA representative (QAFL/QA Sponsor) on CMC projects and communicate with directly with clients about quality issues and updates

2.5              及时完成上级领导交办的其它工作。

Complete assigned tasks by area management in a timely manner

3.0      人员资质 Personal Qualification
3.1              具备医药或相关专业本科以上教育背景,从事相关工作6年以上,熟悉GMP/cGMP/欧盟GMP等法规;

With the education background of medicine or relevant major of bachelor or above, with more than 2 years related working experience, familiar with the GMP/cGMP/EU GMP regulations;

3.2              上岗前各项考核(健康状况、 推荐/资历确认)合格;

Pass the all examinations before onboarding (healthy check , references/background check);

3.3              专精于微软软件(word, excel, powerpoint)及微软Visio的使用;

Expertise in Microsoft Office suite (word, excel, powerpoint) and MS visio

3.4              英语听说读写能力良好。

Good command of English, both in writing and verbally.

3.5              沟通能力良好。具良好的团队精神、并能独立工作。

Good interpersonal and communication skills; work well in a team setting as well as the ability to work independently with minimum supervision.

 

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Associate Director/Director, Biochemistry Lab, Analytical Sciences

WuXi Biologics in Shanghai

Responsibilities:

  • Lead Biochemistry Lab in development of immunoassay and DNA assays activities for protein therapeutics for early and late stage programs, including method development, qualification/validation, method transfer to QC, and strongA collaboration with partner organizations.
  • Lead the efforts in applying high-throughput workstation and analytical technology to support process development.
  • Contribute to draft and review of regulatory submissions including INDs and BLAs.
  • The applicant will manage a large group of scientists, he/she should be an effective communicator of ideas, project goals and results to group members.
  • Hands-on technical leadership of all aspects of anti-host cell protein ELISA, anti-product ELISA and qPCR assay development.
  • Direct scientists in the initiation and execution of laboratory experimentation, considering economic, regulatory and safety factors.

Qualifications:

  • Requires a Ph.D. in biochemistry, or immunology and 8+ years of relevant experience that demonstrates an expertise in assay development and scientific accomplishments.
  • Industry experiences in the development and validation of ELISA and DNA assays for CMC applications.
  • Experiences with high throughput workstation and its applications.
  • Record of scientific technical writing skills as demonstrated by peer-reviewed publications in science and technology journals.
  • Excellent communication skills (both verbal and written) and interpersonal skills are required. Fluent in English and Chinese.
  • Experience interacting with health authorities (FDA, EMA etc.) is a plus.

 

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Department:  QA-SH
Position: Auditing Associate/Assistant Director
Report to: Head of QA-SH
Location:

Building 16 of WuXi Biologics Shanghai site

 

Date: 2018-03-22
Key accountabilities:

1.1      负责GMP自检(内审)管理;

Be responsible for management of GMP Self-Inspection (internal audit);

 

1.2      负责外部供应商审计管理包括,物料供应商、外包测试实验室、计量供应商、承运商;

Be responsible for coordinating and participating supplier audit, including material providers, outsourced testing laboratory, metrological supplier, and carrier;

 

1.3      负责客户审计和药政检查的计划,准备和接待;

Be responsible for Scheduling, preparation and hosting client audit and regulatory inspection;

 

1.4      负责客户审计和药政检查的回复和纠正预防措施的跟踪;

Be responsible for response to observations and follow-up with CAPAs to client audit and regulatory inspection;

 

1.5      负责日常检查的管理;

Be responsible for management of routine inspection;

 

1.6      负责相关SOP的维护和解答;

Be responsible for maintenance and explanations of related SOPs;

 

1.7      负责搜索和提供法律、法规、指南文件相关的信息;

Be responsible for searching and collecting GMP information as to most up-to-date intelligence, regulation and guidelines etc.

 

Requirements:

1.1      具备医药或相关专业本科以上教育背景,从事cGMP质量管理工作10年以上,熟悉cGMP各国法规(CFDA/欧盟/FDA/ICH等法规)及指南;

With the education background of medicine or relevant major of bachelor or above, with more than 10 years related working experience in cGMP quality management, familiar with the GMP regulations and guidelines (CFDA/EU GMP/FDA/ICH etc.);

 

1.2      3年以上管理经验;

With 3+ years of management experiences in managing a team;

 

1.3              熟悉办公软件及统计软件的使用;

Familiar with the operation of statistical software and office software;

 

1.4              有较强的分析问题能力,良好的沟通协调能力;

Problem-analyzing and solving ability, Good communication and coordination skills;

 

1.5              英语口语流利,书面英语良好;

Fluent written and oral English;

 

1.6              能够适应出差。

Available for short term business trip.

 

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合规主任岗位描述

Job Description of Compliance/Investigation/Complaint Director

 

部门/班组:质量保证部

Dept./Group: QA-SH

岗位:合规主任

Position:Compliance/Investigation/Complaint

Director

1.0      汇报范围REPORT RANGE
1.1      直接上级:质量体系系统合规主任

Direct leader: Quality System &Compliance Director

 

1.2      所属下级:合规专员

Subordinate: Compliance Specialist

 

2.0      工作描述JOB DESCRIPTION
 

2.1      负责建立并维护公司质量体系,包括偏差、变更、投诉与不良反应、召回、产品回顾、风险管理等系统;

Responsible for establishing and maintaining the quality system of the company, including the subsystems of deviation, alteration, complaint and adverse reaction, recall, product review and risk management;

 

2.2      负责药品不良反应报告审核,组织质量有关的药品不良反应调查,并报告至国家药品不良反应监测系统;

Responsible for the audit of ADR reports, organizing quality-related ADR investigations and reporting to the national ADR monitoring systemResponsible for the audit of ADR reports, organizing quality-related ADR investigations and reporting to the national ADR monitoring system;

 

2.3      负责产品召回的管理,并定期进行模拟召回,确保召回体系有效性;

Responsible for the management of product recall, and carry out the simulation recall regularly to ensure the validity of the recall systemResponsible for the management of product recall, and carry out the simulation recall regularly to ensure the validity of the recall system;

 

2.4      负责对公司产品相关申报资料进行审核,以完成资料审核工作;

Responsible for the audit of the company's product related declaration, to complete the audit work;

 

 

3.0      人员资质 PERSONAL QUALIFICATION
 

3.1      具备医药或相关专业硕士以上教育背景,从事相关工作5年以上,且熟悉产品召回、退回、资料申报等工作;

With a master's degree or above in medicine or related fields, he has been engaged in related work for more than eight years and is familiar with the work of product recall, return and data declaration With a master's degree or above in medicine or related fields, he has been engaged in related work for more than eight years and is familiar with the work of product recall, return and data declaration;

 

3.2      参与过FDA 、CFDA审计工作;有相关国内外FDA、CFDA审计经验,协助取得GMP相关认证;

Participated in the audit of FDA and cfda; Relevant domestic and foreign FDA and cfda audit experience to assist in obtaining GMP related certification;

 

3.3      良好英语听说读写能力,熟练使用计算机办公软件;

Good English listening, speaking, reading and writing skills, good use of computer office softwareGood English listening, speaking, reading and writing skills, good use of computer office software;

 

3.4      有较强分析问题的能力及良好的沟通技巧,有良好团队合作精神。

Strong ability to analyze problems and good communication skills, and good team work spirit.Strong ability to analyze problems and good communication skills, and good team work spirit

 

 

 

 

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Job Title: Assistant/Associate Director (Project Management)

Company introduction:

Wuxi Biologics is a world-class CMO with the most comprehensive capability and technology platform serving clients globally in the biopharmaceutical and health care industries from discovery to commercialization.  The company is publically listed in Hong Kong, with a market capital of $13 billion.  Our dream is to ensure “every drug can be made and every disease can be treated” to become a reality for both Wuxi Biologics and our clients/strategic partners.  The company has sites/offices in China, US, EU, Asia and Israel.  The company currently has 3,000 employees, and are providing services to over 200+ clients globally, including 13 of the top 20 biopharmaceutical companies.

 

Job Description:

  1. The scope of the position will manage the Process Technology & Project Management (PTPM) department for technical projects. Specific activities will include, but not limited to, facility fit, working with strategic partners/clients to address their needs and relationship management.
  2. The facility fit activities will include evaluating the project from equipment availability, size, quantity and time, or any of the combination to ensure the success of transferring a project into our cGMP manufacturing facility.
  3. The candidate will need to have extensive biologics manufacturing processes from media preparation, buffer preparation, inoculation, seed transfer/expansion, GMP production, harvest, loading products onto columns (Protein A, Cation Exchange, Anion Exchange), viral inactivation, viral removal, concentration, UF/DF and Bulk fill of drug substance into bottles.
  4. The candidate will occasionally lead the investigation of deviations.
  5. The candidate will interact with supporting groups (PEV, Engineering, QC, QA, AIS, EHS, etc.) to ensure the manufacturing operations running smoothly and seamlessly.
  6. The candidate will work with the cross functional team to address and resolve issues and report any incompliant & technical issues to department heads and senior management.
  7. This person should have extensive experience in biopharmaceutical industry.
  8. Candidates with experience in downstream processing (DSP), Upstream processing (USP), QC, QA , Process Development (PD), equipment & process validation or Manufacturing Science and Technology (MSAT) experience will be considered.
  9. The candidate must know how to use Microsoft Excel, MS Project and Powerpoint.
  10. The candidate will work on any other tasks to be assigned by the company.

 

 

 

Qualifications:

Education:  BS, or MS or PhD in Chemical Engineering, Bioscience, or Biotechnology.

Experience required:  10-20 years in biopharmaceutical manufacturing, Project Management, Upstream Processing, Downstream Processing, QC, QA, MST, Engineering or PEV. 

Other: The candidate must have the following attributes: Can do attitude, good organizational skill, attention to details, strong communication skill, team-oriented, leadership skill and work well with people.

Equal Opportunity Employer Minorities/Women/Veterans/Disabled

 

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Job Title: Ass. Director/Director/Sr. Director, Purification

Job Description

The candidate will lead a group of 50+ people in the clinical/commercial downstream processing (DSP) area.  The individual will perform analysis of historical data to support process scale-up across facilities in clinical & commercial manufacturing. This will include troubleshooting observed process differences as well as deriving and improving current scaling techniques and tools. The position will also entail process characterization, hands-on purification using GE AKTA system at pilot/commercial scale along with the associated experimental planning, coordination, and report writing.  The candidate need to have experience in leading a team, a goal oriented mindset, and a can-do attitude.  The candidate will work with Upstream Processing (UPS), QA, QC, Engineering, Supply Chain, PD, Planning, Regulatory, Logistics, Project Management and Procurement.

 

Qualification

The position requires a strong industry background with at least 10-15 years of experience. The ideal candidate will have proficiency in operating a drug substance pilot plant and/or a commercial facility in the downstream processing arena. Expertise and specific experiences modeling chromatography skids. Hands-on experience with various size columns. The candidate needs to understand the effects of DSP parameters on recovery and yield. The individual need to have good understanding in DQ, FAT, SAT, IQ, OQ, & PQ (commissioning and qualification).  The candidate must have experience in dealing with FDA, and have a solid understanding of quality system in terms of deviation, investigation, CAPA and change control. The individual should have experience in CIP, SIP, clean room and water system (Purified Water, pure steam, and WFI). The individual should have strong communication, team-oriented, and leadership skills

 

Education:

BS, MS or PhD in Chemical Engineering, Bioscience, and Biotechnology.

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Job Title: Ass. Director/Director/Sr. Director, Cell Culture

Job Description

The candidate will lead a group of 20-50 people in the clinical/commercial downstream processing area.  The individual will perform analysis of historical data to support process scale-up across facilities in clinical & commercial manufacturing. This will include troubleshooting observed process differences as well as deriving and improving current scaling techniques and tools. The position will also entail vessel characterization, hands-on cell culture fermentation at pilot/commercial scale along with the associated experimental planning, coordination, and report writing.  The candidate need to have experience in leading a team, a goal oriented mindset, and a can-do attitude.  The candidate will work with QA, QC, Engineering, Supply Chain, PD, Planning, Regulatory, Logistics, Project Management and Procurement.

 

Qualification

The position requires a strong industry background with at least 10-15 years of experience. The ideal candidate will have proficiency in operating a drug substance pilot plant and/or a commercial facility. Expertise and specific experiences modeling bioreactors applying oxygen mass transfer, power per volume, carbon dioxide stripping models, vessel mixing characterization, eddy size application, hydrodynamic shear, etc. is preferred. The candidate should have a strong background in cellular metabolism, various mammalian cell lines, and be scientifically minded. In addition, the candidate should have knowledge and experience designing bioreactor vessels with corresponding understanding of how key design attributes impact process performance. Hands-on experience with various size bioreactors (both single use bioreactor (SUB) and traditional SS tank) and applying the previously mentioned techniques across those scales is desired. The individual need to have good understanding in DQ, FAT, SAT, IQ, OQ, & PQ (commissioning and qualification).  The candidate must have experience in dealing with FDA, and have a solid understanding of quality system in terms of deviation, investigation, CAPA and change control. The individual should have experience in CIP, SIP, clean room and water system (Purified Water, pure steam, and WFI). The individual should have strong communication, team-oriented, and leadership skills.  Candidate should have stainless steel and Single-Use System experience.

 

Education:

BS, MS or PhD in Chemical Engineering, Bioscience, and Biotechnology.

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Job Category:                 MSAT Downstream Process   

Job Title:                           Scientist/ Engineer II, III
Associate Director, Director I/ II, Senior Director

Responsibilities:  This position is in the Manufacturing Science and Technology (MSAT) Department of WuXi Biologics.  The successful candidate will undertake or lead all activities in early and late stage technology transfer, process validation, process monitoring and continued process verification (CPV), and take part in Quality System support and improvement.  The successful individual will participate in all CMO project team activities, and potentially direct the efforts of junior MSAT staff with the intention of supporting manufacturing campaigns to produce clinical phase II & III and BLA-enabling materials.  The successful candidate is expected to work routinely with teams within the cGMP Manufacturing organization (Drug Substance MFG, Drug Product MFG, Process Engineering & Validation, Automation, Engineering, QA, QC) as well as to collaborate with other cross-functional teams including CMC, Project Management (PM), Process Development, and Analytics and Formulation Development.

Requirements:  Required specialized skills include a deep conceptual understanding of separation principles and a thorough knowledge of recovery separation and purification techniques, analytical assays, small and large scale processing equipment, and cGMP.  The successful candidate should possess good problem-solving abilities and organizational and documentation skills with a strong focus on details and results.  The successful candidate should be self-motivated and able to work independently as well as in a team environment.  This individual should be a strong team player and have excellent written and oral presentation skills.  Fluency in English writing and speaking is a plus.  The position requires leadership skills for direct reports as well as cross-functional teams.

Education:  Minimum a 4-year college degree in the area of Biochemistry, Biological Sciences, or Biochemical/ Chemical Engineering.  Previous Biotech industry experience is desirable.

  • D. with 4+ years of proven experience and accomplishment
  • S. with 6+ years of proven experience and accomplishment
  • S. with 8+ years of proven experience and accomplishment

Contact[email protected], 186-5726-5618 (China)

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Job Category:                 MSAT Upstream Process   

Job Title:                           Scientist/ Engineer II, III
Associate Director, Director I/ II, Senior Director

Responsibilities:  This position is in the Manufacturing Science and Technology (MSAT) Department of WuXi Biologics.  The successful candidate will undertake or lead all activities in early and late stage technology transfer, process validation, process monitoring and continued process verification (CPV), and take part in Quality System support and improvement.  The successful individual will participate in all CMO project team activities, and potentially direct the efforts of junior MSAT staff with the intention of supporting manufacturing campaigns to produce clinical phase II & III and BLA-enabling materials.  The successful candidate is expected to work routinely with teams within the cGMP Manufacturing organization (Drug Substance MFG, Drug Product MFG, Process Engineering & Validation, Automation, Engineering, QA, QC) as well as to collaborate with other cross-functional teams including CMC, Project Management (PM), Process Development, and Analytics and Formulation Development.

Requirements:  Required specialized skills include a deep conceptual understanding of cell culture principles and a thorough knowledge of media and feed development, cell culture techniques, small and large scale processing equipment, and cGMP.  The successful candidate should possess good problem-solving abilities and organizational and documentation skills with a strong focus on details and results.  The successful candidate should be self-motivated and able to work independently as well as in a team environment.  This individual should be a strong team player and have excellent written and oral presentation skills.  Fluency in English writing and speaking is a plus.  The position requires leadership skills for direct reports as well as cross-functional teams.

Education:  Minimum a 4-year college degree in the area of Biochemistry, Biological Sciences, or Biochemical/ Chemical Engineering.  Previous Biotech industry experience is desirable.

  • D. with 4+ years of proven experience and accomplishment
  • S. with 6+ years of proven experience and accomplishment
  • S. with 8+ years of proven experience and accomplishment

Contact[email protected], 186-5726-5618 (China)

 

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Senior Scientist III/IV, Downstream Development

 

Description

Downstream Process Development Wuxi subdivision is responsible for purification process development, scale-up, technical transfer, process characterization, and support for pre-clinical, clinical, commercial manufacturing, and regulatory filing.

 

Senior Scientist III/IV Responsibilities:

  • Design the downstream processes that are efficient, robust and scalable for the clinical manufacturing and commercial production.
  • Lead a purification process development project
  • Effectively and timely communicate with clients, maintain and build up good relationship with clients, and being responsible for company images and reputation
  • Actively cooperate with other department colleagues to fulfill assigned tasks and in line with department decision
  • Prepare dossiers and data packages to assist with the interactions with Regulatory agencies.
  • Assist his/her manager and functional head to coordinate the work between the downstream development group and other functional groups to meet the project objectives and timelines.
  • Coach and lead his/her team staff on process development.
  • Manage his/her team effectively in a fast paced environment.
  • Follow company code of conduct and compliancy
  • Follow and improve laboratory regulation

Basic Qualifications:

  • BSc with 10+ years, MSc with 6+ years, or PhD with 2+ years downstream process development experience.
  • People management experience is plus.
  • Chinese and English language skill in reading, writing, and speaking.
  • Experience in Downstream process development, knowing all modes of chromatography, various filtrations, centrifugation, and how to assemble various steps into a purification process.
  • Experience with Design of Experiments.
  • Have a good understanding of the limitations of manufacturing when designing purification processes.
  • Experience in downstream process scale-up, technical transfer, and production troubleshooting.
  • Experience in downstream process characterization and validation is plus
  • Experience in regulatory submission to CFDA, FDA, and EMA.

Job Function: Research & Development

Primary Location: China –Wuxi

 

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Due to the rapid expansion of Wuxi Biologics, we are seeking candidates with various backgrounds for middle to senior level of management and program managers at our Wuxi, Jiangsu site.

Responsibilities:

  • Overseeing assay development activities (immunoassay, or chromatography, or LC-MS) to support the development, characterization and manufacture of protein therapeutics, including method development, qualification/validation, transfer; and supervision of technical staff.
  • Work effectively with cross-functional team members, domestic and international clients to ensure that the set project goals, timelines and deliverables are met.
  • Review and approve analytical test results and reports; contribute to the draft and review of regulatory submissions including INDs and BLAs.
  • Provide oversight and guidance towards operational and technological excellence and innovation within Protein Analytical Science department.

Basic Qualifications:

  • Master or Ph.D. in biochemistry, biophysics, chemistry, molecular biology or other related fields, prefer to have some relevant experience in biopharmaceutical or biotechnology industry.
  • Excellent communication skills (verbal and written) in both English and Chinese are required. Oversea experiences or degrees would be plus.
  • Record of scientific technical writing skills as demonstrated by peer-reviewed publications in science and technology journals.
  • Previous managerial experience of tech staff or project is a plus.

 

Primary Location: China – Wuxi

 

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Associate Director/Director, Downstream Development

 

Description

Downstream Process Development Wuxi subdivision is responsible for the purification process development, scale-up, technical transfer and support for the pre-clinical and clinical manufacturing at Wuxi AppTec biological facility in Wuxi, China. The scope of downstream process development includes the cell culture clarification (centrifuge and depth filtration), column chromatography, viral inactivation/removal, and ultrafiltration/diafiltration.

The Associate Director/ Director is responsible for managing a downstream development sub-team to develop the scalable protein purification processes for the pre-clinical and cGMP clinical manufacturing, troubleshoot the issue of manufacturing, and execute downstream process validation.

Responsibilities:

  • Design the downstream processes that are efficient, robust and scalable for the clinical manufacturing.
  • Assist the director to coordinate the work between the downstream development group and other functional groups to meet the project objectives and timelines.
  • Oversee the process scale-up and technology transfer between the process development team and manufacturing team.
  • Coach the group leads and staff on the process development and validation.
  • Manage the activities for the validation of the downstream processes.

Basic Qualifications:

  • MS with 10+ years, or PhD with 6+ years downstream process development experience.
  • At least 4 years’ people management experience
  • Experience in the large-scale chromatography, centrifuge and depth filtration harvest, ultrafiltration/diafiltration, and viral inactivation and removal
  • Experience in downstream process cGMP production.
  • Experience in downstream process validation
  • Experience in working with the cross-functional teams.
  • Experience in troubleshooting and investigation of the critical deviation, and making the risk analysis on the development, technical transfer and process validation.
  • Experience in regulatory submission to FDA/EMA.

Job Function: Research & Development

Primary Location: China –Wuxi

 

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Job Introduction

  • Tile: Group Leader I/II, Assistant/Associate Director
  • Department: Bio Dev, Protein Science
  • Location Wuxi, China

 

Job Responsibility

  • Lead a team of scientists to execute research material generation (RMG) activities in support of biotech product portfolio
  • Manage FFS/FTE RMG projects and build client relationship
  • Ensure compliance to regulatory requirement, including instrument maintenance, personnel training, document drafting, review and archiving.
  • Technical transfer, training and trouble-shooting of protein purification procedures for the downstream process development purposes
  • Thorough understanding of biochemistry, protein engineering, protein analytics and immunology.
  • Solid hands-on skills in protein purification and characterization, especially antibodies and fusion proteins
  • Other responsibilities may be added at the company’s discretion

 

Basic Requirement

  • Industrial experience:2-5 years
  • Major:Biochemistry, Biophysics, Immunology, Protein Chemistry, or related field
  • Degree:D.
  • Language:English/Chinese
  • Managing experience:Preferred but not necessary
  • Gender:NA

 

Professional Requirement

Mandatory:

  • Extensive experience in protein production
  • Broad expertise and familiarity with protein purification and characterization platforms
  • Proficient in AKTA systems
  • Ability to independently design and perform experiment, execute project coordination and data analysis
  • Demonstrated project lead experience in an academic or industrial research setting
  • Good communication skills required, including writing and presentation
  • Strong team-working spirit, excellent communication and personal skills
  • Proven experience with mentoring and training junior scientists

Preferable:

  • Proven skills of antibody engineering
  • Hands-on experience with high-throughput or automated purification system
  • Experience with structural biology
  • Assay development and validation experience
  • Proficiency in DOE tools

 

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Department:  上海质量保证部QA-SH
Position: QA 项目负责人/产品放行

QA Project Lead/ Product Release

 

Report to: Debbie_Lou

        

Location: 26-301

 

Date: 2018-02-02
Key accountabilities:

 

1.1     负责GMP生产过程中所有质量问题的追踪。

Be responsible for tracing all quality questions in the GMP manufacturing process.

1.2     负责维护公司与客户的关系,并与客户QA之间进行良好沟通。

Be responsible for maintaining the relationship both the client and company and communicating with the client smoothly.

1.3     参加与客户之间的日常质量会议,反馈/解决相关的质量问题。

Attend the daily quality meeting with the client and raise/ solve the relevant quality questions.

1.4     负责解答客户QA与内部QA的问题。

Be responsible for answering the questions between client QA and internal QA.

1.5     负责追踪与项目有关的偏差,CAPA和变更。

Be responsible for tracing the relevant deviation, CAPA and change control for the project.

1.6     参加项目的现场审计工作。

Attend the audit work for project.

1.7     按时参加与项目管理部之间的日常会议。

Attend the daily CMC meeting on time.

1.8     负责审核已执行的生产记录,收集放行相关的文件并完成批放行。

Be responsible for reviewing the executive MBR, collecting the relevant documents to complete the batch releasing.

1.9     协助优化相关放行流程和相关SOP的升级。

Assistant to optimize the releasing process and update the relevant SOPs.

1.10  定期组织放行会议跟踪放行进展。

Organize the release meeting periodically and trace the progress.

1.11  负责原液及产品的放行工作。

Be responsible for the release testing

1.12  完成领导安排的临时工作。

Complete the temporary work by the director.

Requirements:

 

1.1     本科以上或同等学历,专业为化学、生物、生物化学、化学工程、生物工程等。

College degree or above with a major in chemistry, biology, biochemistry, chemical engineering, bioengineering, or related field.

1.2     在相关的生物制药行业工作6年以上,对此行业动向具有一定的了解。

More than 6 years working the relevant biological pharmacy industry and be familiar with the progress.

1.3     4年以上在制药、生物、医疗器械生产等领域的直接QA经验。

More than 4 years direct working experience in QA in pharmaceuticals/biotech/medical device manufacturing or related fields.

1.4     良好的沟通协调能力。

Good communication and coordination skills.

1.5     听说流利,读写熟练。

Listening and speaking fluently, be good at reading and writing.

1.6     具有4年以上的质量系统管理经验。

More than 4 years for quality management experience.

1.7     具有2年以上的管理团队经验。

Manage the team with more than 2 years experiences.

 

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Auditing QA assistant director

Job Responsibility

  1. Manage the scheduling, planning and execution of the annual internal audit (Self-inspection)
  2. Responsible for management, execution and follow-up of supplier audit.
  3. Schedule, prepare and host client audit and regulatory inspection.
  4. Response to findings from client audit and regulatory inspection and follow-up CAPAs.
  5. Responsible for planning and execution of routine inspection.
  6. Responsible for maintenance and explanations of related SOPs.

 

PERSONNEL QUALIFICATION

  1. Bachelor degree or higher. Major in biology, pharmacy, chemistry, or other related major.
  2. 8 years experience of QA in pharmaceutical industry is preferred.
  3. Well verse in spoken and written English language, Skillful in using computer software.
  4. Excellent communication, problem-solving, and organization skills, Attentive, careful and meticulous, with strong team-work ability.

 

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Training Assistant Director

JOB RESPONSIBILITY

  1. Lead and coordinate GMP training program within QA for all GMP staff within Wuxi Bio across all sites;
  2. Create and maintain Training system in WuXi Biologics;
  3. Draft and maintain training SOPs;
  4. Conduct and facilitate related GMP classroom training at the Wuxi site;
  5. Maintain and qualify all GMP Job Module at the Wuxi site;
  6. Organize and schedule annual re-training;
  7. Create/revise training materials for intended purpose;
  8. Annual training requirement organization;
  9. Training document management, including training materials, records, personal binder, etc.;
  10. Track and report training status;
  11. Be responsible for developing and procedure maintaining of training in Master Control;
  12. Take part in the implement of training project derived from PAI;
  13. Specify responsibilities refer to the job modules selected by supervisor.

PERSONNEL QUALIFICATION

  1. Bachelor degree or above, major in biology, pharmacy, human resource management or equivalent;
  2. At least 2 years of working experience in pharmaceutical and training plant, prior experience in training management is preferred.
  3. Well verse in spoken and written English language, Skillful in using computer software.

 

 

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Senior Director, Microbiology and Environmental Monitoring, Quality Control

WuXi Biologics in Shanghai

Responsibilities:

  • Lead Microbiology and Environmental Monitoring, and Raw Material management and testing functions in clinical QC organization.
  • Provide guidance and oversee method qualification/validation, troubleshooting, laboratory and OOS investigation and promote collaboration with partner organizations.
  • Comply with Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP). Strong knowledge of GMPs and quality systems with experience managing deviation, change control, and CAPA. Assist regulatory audit and inspections.
  • Lead quality control system improvement initiatives. Projects may include writing and reviewing QC SOPs, designing and implementing systems (LIMS, E-notebook etc.).
  • Develop training program. Ensure all staff receive training in basic cGMP training, applicable techniques and SOPs.
  • Develop talent, inspire innovation and operational excellence and foster a continuous learning and improvement environment.
  • Draft and review of relevant CMC sections for regulatory submissions including INDs and BLAs.
  • Should be an effective communicator of ideas, project goals and results to cross-functional team members.

Qualifications:

  • Requires a Ph.D. in microbiology, biochemistry, or related life sciences degree and 12+ years of relevant experience that demonstrates an expertise in assay qualification/validation, release and stability testing and QC operations.
  • Extensive hands-on experience in microbiology, environmental monitoring, raw material testing and QC operations in cGMP environment. Experiences in international biopharmaceutical company is preferred.
  • Excellent communication skills (both verbal and written) and interpersonal skills are required. Fluent in English and Chinese.
  • Managerial experience by providing on-going mentoring, supervision, and yearly performance review and appraisal of a large group of scientists.
  • Experience interacting with clients and health authorities (CFDA, FDA, EMA etc.) preferred.

科伦药业,生物统计与数据管理 ,成都

科伦药业招聘:生物统计与数据管理 地点:成都

 

生物统计师: 工作职责

1、参与临床项目方案设计:样本估计、主要与次要终点指标选择、统计目的与假设设定、 制定统计分析方案;

2、临床运营支持:随机与盲法的设计与实施、随机相关人员培训;

3、撰写统计相关文档:负责撰写 SAP 与 SAR、QC 程序员统计分析结果、审核临床研究报告;

4、统计分析外部资源管理。 任职要求

1、学历要求:

博士学历。

2、专业要求:

生物统计及相关专业。

3、工作经验和能力要求:

有 2 年以上生物统计师工作经验优先;熟悉国家统计分析相关法规与指导原则。

4、职业素养:

认真负责、主动、好学、勤于思考,有较强的团队意识、良好的沟通能力、能认同公 司文化。

 

 

 

统计分析师: 工作职责

1、数据管理方面:编写 SAS 程序实施 EDC 数据线下核查、按照 CDISC 标准对 EDC 数据进行 标准化;

2、统计分析方面:使用 SAS 软件进行统计分析,按照要求出具标准统计表格与图表;

3、宏程序开发:开发属于本公司专利优质的宏程序。 任职要求

1、学历要求:

硕士及以上学历。

2、专业要求

统计或数学相关专业、计算机相关专业、医学统计专业

3、工作经验和能力要求:

能熟练使用 SAS、R 统计分析软件,有两年以上 SAS 编程经验者优先。

4、职业素养

认真负责、主动、好学、勤于思考,有较强的团队意识、良好的沟通能力、能认同公 司文化。

 

 

数据管理师: 工作职责

1、参与临床方案的审阅,协助医学撰写和统计师完成方案的定稿;

2、设计 CRF,与医学撰写和统计师在规定的时间内完成 CRF 的定稿;

3、协助完成数据库建库,进行数据库的测试,保证 EDC 按照指定的时间上线;

4、全程管理临床试验的数据管理活动,撰写相关文档:如数据管理计划、数据核查计划、 CRF 填写指南、SAE 一致性核查计划、外部数据的传输文档、数据管理报告等;

 

任职要求

1、学历要求:

硕士及以上学历。

2、专业要求:

医学、公共卫生、预防医学、流行病学及相关专业。

3、工作经验和能力要求:

有 2 年以上数据管理工作经验优先;熟悉数据管理法规与指导原则。

4、职业素养:

认真负责、主动、好学、勤于思考,  有较强的团队意识、良好的沟通能力、能认同公司文化。 联系人: 王辉,邮箱:[email protected];  微信: huiwang189

Rockland Immunochemicals, Inc. CSO opines “Benefits of Polyclonal Antibodies” in peer-reviewed article

Limerick, PA. August 9, 2018 – Rockland Immunochemicals, Inc. announced today that Dr. Carl Ascoli, Chief Science Officer at Rockland, and Dr. Birte Aggeler, Director of Antibody Development at Bio-Techne, composed a peer-reviewed article using their combined experience of more than 50 years. The review article was published online on August 9, 2018 and will be printed in the September 2018 issue by the journal BioTechniques. The review article, entitled “The Overlooked  Benefits of Polyclonal Antibodies,” discusses the pros and cons of polyclonal, conventional monoclonal, and recombinant monoclonal antibodies, while presenting procedures for experimental design, the inclusion of relevant controls, and validation strategies for polyclonal antibodies.

 

Antibodies are critical reagents most often used by life science and translational medicine researchers and are transformative tools used to diagnose and treat disease. Many 21st century medical breakthroughs were successful in part to antibody technology. Yet antibodies, especially polyclonal antibodies, are caught in a firestorm of controversary concerning data reproducibility. Ascoli stated “by emphasizing the appropriate role polyclonal antibodies may play in conducting life science research, our efforts here should improve upon the use of antibodies, the collection of reproducible data, and the expansion of antibody-based technologies.”

 

Thoughtful antibody design and development allows for polyclonal antibodies to be used in many different applications, techniques, and instrumentation. Ascoli explained that “while some have called for polyclonal antibodies to be phased out of research entirely, we believe in using ‘the right tool for the job’ which includes using all forms of antibodies, polyclonal, conventional monclonal, and recombinant monoclonal, in the appropriate context and according to the manufacturer’s recommendations.” When using polyclonal antibodies, it is particularly important to use appropriate positive and negative controls and to assure immunoassay-specific antibody validation on a lot-to-lot basis. This review article presents the value of polyclonal antibodies for research, discusses strategies to minimize their disadvantages, and suggests when other forms of antibodies are more appropriate.

 

#  # #

 

Rockland Immunochemicals, Inc., (Rockland) provides the highest quality antibodies and antibody- based life science tools and services to the academic, biopharma, and diagnostic industries for use in basic research, assay development, preclinical and clinical studies, and bioprocessing. With facilities in Pennsylvania for over 55 years, Rockland manufactures products ideally suited for integration into critical assays such as western blotting, immunohistochemistry (IHC), immunofluorescence microscopy (IF), ELISA, flow cytometry, and 2D imaging. Additional information about Rockland’s life science tools and services can be found on Rockland’s website at  www.rockland-inc.com.

 

Christina Rowley

Marketing Communications Manager Rockland Immunochemicals, Inc.

Phone: 484.791.3823

Email: [email protected]

 

 

Like Rockland on Facebook

 

Follow Rockland on Twitter @rockland_inc

Wuxi Apptec, multiple positions, China & US

Department: ATU
Position:    Business Development Assistant Director
Report tosite GM
LocationShanghai Date: May 14, 2018
 

Job Summary:

Leads the business development activities to find and cultivate client business opportunities that result in increasing revenue for WuXi AppTec in the area of Cell and Gene Therapy manufacturing.

Essential Job Functions:

 

·         Responsible for growing revenue in the Cell & Gene manufacturing business unit.

·         Generates leads and closes business for autologous and allogeneic cell therapy, whole cell vaccine projects, gene-mediated cell therapy and gene therapy manufacturing programs in Philadelphia.

·         Represents the company and interacts with clients either at the client’s site or at a WuXi AppTec facility during client visits, and also at tradeshows/conferences.

·         Effectively communicate features and benefits and capabilities of WuXi AppTec’s manufacturing services and other associated services.

·         Follows up on all leads either generated personally, via internal/inside sales, regional account managers or senior management.

·         Collects and disseminates accurate and complete information from clients to internal technical staff to understand the scope of work.

·         Writes and develops proposals and contract templates. Works with operational staff to define project scope and combine with existing capabilities to generate the scope of work and provide timely price quotations/proposals.

·         Assists in reviewing, writing and negotiating contract terms and conditions.

·         Along with Sales Management, leads in directing the inside sales prospecting efforts.

·         Follows up on quotations for purposes of both gathering client feedback and expediting client decisions.

·         Completes paper work (i.e., sales/call reports, quote requests, and expense reports) and updates Client Relationship Management (CRM) tool in a timely manner.

·         Maintains up to date knowledge of the cell and gene therapy fields/industries, technical and regulatory aspects as it relates to the position and the CMO competitive landscape.

·         Provide support and leadership to strategic initiatives in support of the biologics services business as needed.

·         Perform research and develop market analysis or presentations on the business unit or service areas as requested by management.

·         Performs special projects and other duties as required.

  • Works on routine assignments per written procedures, where ability to recognize deviation from accepted practice is
  • Ability to work in a team environment and independently as required
  • Contributes to the overall operations and to the achievement of departmental goals
  • Perform job specific tasks in compliance with applicable Regulations, International Standards, and WuXi AppTec Policies and Standard Operating
  • Thorough understanding  of  Good  Laboratory  Practices  and  Good  Manufacturing Practices
  • Other duties as assigned
  • May be required to assist in other departments

Job Requirements: Experience / Education

  • 7 or more years of relevant experience
  • Bachelors’ degree in Marketing/Business or Life Sciences required, Masters’ preferred or equivalent experience

Knowledge / Skills / Abilities:

 

  • Extensive knowledge of the CMO & biotech/biologics industries.
  • Demonstrated success at managing multiple opportunities and projects
  • Ability to work effectively as part of a team and to exhibit effective interpersonal
  • Ability to receive and comprehend and to effectively communicate detailed scientific and business information through verbal and written communication.
  • Understanding and  familiar  use  of  Microsoft  Office  products  such  as  Word,  Excel, Powerpoint and
  • Strong written and oral communication skills.
  • Outstanding organizational and time management
  • Demonstrated ability to work under pressure.
  • Excellent interpersonal
  • Ability to work effectively with customers and internal
  • Ability to use judgment as dictated by complexity of
  • Proficient in Oral & Written communication skills
  • Need to be able to read, write and understand English
  • Proficient in Microsoft (Excel, Word, Outlook)

 

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Job Title:                                          Regulatory Affairs Associate Director

Reports to (Title):                           V.P. of Operation

Location:                                          Shanghai

Exempt/Non-Exempt:                    Exempt

Direct Reports :                              No

Department:                                     RA

Cost Center:

EEO Job Category                         Professional

 

Job Summary: The Regulatory Affairs Associate Director is responsible for preparing on-time filing of high-quality regulatory submissions, regulatory and technical documentation to support and obtain regulatory approvals, post-approval maintenance of regulatory dossiers, and maintain both quality and regulatory compliance.  In addition, this position will interact with project teams and regulatory agencies in relation to submissions, compliance, and other relevant topics.

 

Essential Job Functions:

 

  • Participates in the development and implementation of the regulatory strategy: compiles information and data pertaining to regulatory and project requirements; assesses needs; identifies the project’s critical factors; presents decision-makers with options; applies
  • Assembles a regulatory file/dossier: coordinates acquisition of all applicable data; assessed data; drafts and submits the regulatory
  • Monitors product files in the developmental phase: updates data; reconciles requests from authorities based on scientific and ethical constraints; makes amendments/changes and submits them to
  • Conducts regulatory monitoring of approved products: assists and supports in-house teams; maintains files current; ensures regulatory compliance; evaluates the effects of an amendment/change; takes appropriate regulatory
  • Provides counselling to internal and external clients with regulatory issues: ensures regulatory monitoring; formulates a regulatory opinion; supports employees and the management team; represents the company; conveys information about regulatory matters and their
  • Communication and Interpersonal Skills: Ability to build relationships of trust and demonstrate professional
  • Preparation, Submission, and Follow-up of a Regulatory File
  • Properly documents all file
  • Diligently verifies that collected data comply with the regulations in
  • Conducts proper assessments in order to anticipate questions and critical
  • Clearly responds to questions from regulatory

 

  • Justifies position (legal, ethical, or scientific) when there are differences of opinion in connection with a request from regulatory
  • Regularly monitors commitments/obligations in response to regulatory requirements or
  • Provides operational support for Quality, Manufacturing and Testing activities as it relates to Regulatory and Compliance
  • Works on routine assignments per written procedures, where ability to recognize deviation from accepted practice is
  • Normally receives minimal instructions on routine work and detailed instructions on new
  • Performs support functions for Quality Assurance
  • Ability to work in a team environment and independently as required
  • Contributes to the overall operations and to the achievement of departmental goals
  • Perform job specific tasks in compliance with applicable Regulations, International Standards, and WuXi AppTec Policies and Standard Operating
  • Thorough understanding of Good Laboratory Practices and Good Manufacturing Practices
  • Other duties as assigned

 

Job Requirements: Experience / Education

  • 5-7 years of relevant experience or equivalent
  • A university degree in science (bachelor’s, master’s, doctorate) biology, chemistry, biochemistry, or a related discipline e. regulatory affairs

Knowledge / Skills / Abilities:

  • Autonomy and
  • Ability to communicate effectively, negotiate, and
  • Ability to work on multiple projects at the same
  • Ability to keep tight deadlines and work under

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.

 

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Job Title:                                          Senior Project Manager

Reports to (Title):                           Supervisor or higher

Location:                                          Wuxi or Shanghai

Exempt/Non-Exempt:                    Exempt

Direct Reports :                              No

Department:                                     Project Management Cost Center:

EEO Job Category                         Professional

 

Job Summary: Leads the orderly progression of projects from the proposal stage through project completion by interacting with the client, technical staff and business development staff. Advocates for the client within WuXi AppTec and with WuXi AppTec’s subcontractors. Represents WuXi AppTec’s best interests before clients.

Essential Job Functions:

  • Manages Medium Projects within functional reporting structure or business unit in addition to managing smaller
  • Manages Some Key accounts and Produces Metrics for Each Accounts Performance
  • Custom Quote and Proposal Development with Some Ownership and accountability for bringing Project to Fruition
  • Leads the orderly progression of projects from the proposal stage through project completion by interacting with the client, technical staff and business development
  • Keeps clients updated in a timely manner regarding progress of project, decision points, and events through teleconferences, e-mails, site visits or other suitable
  • Maintains project documentation - communications, schedules, sample submission paperwork, meeting minutes,
  • Informs internal resources of project updates / timely communications
  • Some Custom Quote and Proposal Development with assistance of Technical Team
  • Logs in Projects into OTS and maintains correct pricing as per the executed contract
  • Ensures that testing is performed as per executed contract and brings all scope changes to the attention of
  • Invoices Projects as per the executed contract
  • Normally receives minimal instructions on routine work and detailed instructions on new
  • Contributes to the overall operations and to the achievement of departmental goals
  • Perform job specific tasks in compliance with applicable Regulations, International Standards, and WuXi AppTec Policies and Standard Operating
  • Thorough understanding of Good Laboratory Practices and Good Manufacturing Practices
  • Other duties as assigned
  • May be required to assist in other departments

Job Requirements: Experience / Education

  • 5 +years of relevant experience or equivalent
  • Bachelors’ degree in Biological Sciences or equivalent experience

Knowledge / Skills / Abilities:

  • Understanding and Technical Knowledge of the Organization's Core Business to contribute to Overall Business Aims
  • Broad and Deep Understanding of Project Management Principles
  • At least 5 years of relevant Project Management
  • Training and  experience  in  Good  Laboratory  Practices,  Good  Manufacturing Practices and/or Good Tissue Practices
  • Proficient in Oral & Written communication skills
  • Need to be able to read, write and understand English
  • Proficient in Microsoft (Excel, Word, Outlook)

Physical Requirements:

  • Must be able to work in an office environment with minimal noise
  • Must be able to work in Lab setting with Biohazards /various Chemicals
  • Must be able to wear appropriate PPE
  • Must be able to work in environment with variable noise levels
  • Ability to stand /Sit/walk for long periods of time
  • Ability to Lift 10 lbs routinely
  • Ability to crouch, bend, twist, and reach
  • Ability to push/pull 10 lbs routinely/ often / occasionally
  • Clarity of Vision
  • Ability to identify and distinguish colors
  • Must be able to perform activities with repetitive motions
  • Ability to climb Ladders / Stairs / Scaffolding
  • Ability to work in variable temperatures high to freezing
  • Inside/outside working conditions

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.

 

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Job Title:             Senior Director of Gene Therapy Vector cGMP Manufacturing Operations

Department:        Gene Therapy Vector

Reports To:            GM

Location:                Wuxi Huishan district

 

JOB SUMMARY

Responsible for the daily operations in Gene Therapy Vector manufacturing and facilities. Knowledge of cell and gene therapy manufacturing and support systems is essential. Demonstrated managerial skills and a strong working knowledge of the regulatory compliance.Responsible for hiring, training, supervising and evaluating staff. Remains current regarding technical manufacturing requirements and develops / modifies production methods to fully address such issues. Prepares validation protocols, SOPs, material specifications and develops new client master batch records. Manages Gene Vector manufacturing operations assuring customer satisfaction and compliance with appropriate regulatory standards including but not limited to the U.S. and China GMP regulations.

 

POSITION RESPONSIBILITIES:

  • Responsible for representing Manufacturing in the build-out, commissioning and validation of the GMP Gene therapy vector facility
  • Determining staff and equipment resources.
  • Identification and development of Standard Operating Procedures (SOPs), Master Batch Records, and Product Specification
  • Staffing and training of the assigned Manufacturing group to be competent in current Good Manufacturing Practices (cGMP).
  • Interacts with Engineering, Maintenance, Validation, Quality Assurance, Quality Control, and Materials Management As needed, interaction will be required with material/equipment vendors and clients.
  • Supervises, plans and reviews operations for assigned staff, including responsibility for training, managing and evaluating as well as coordinating, scheduling and assigning work and maintaining facility's
  • Recommends hire/transfer/promotion/discharge and salary changes and acts on employee
  • Conducts employee performance appraisals in a timely and objective
  • Maintains production schedule to meet customer and business
  • Provides accurate production forecasting methods with continuous improvement through capacity optimization and cost reduction
  • Implements and maintains personnel policies, procedures and production control systems.
  • Ensures cGMP compliance, ensuring that all production equipment is properly validated and production processes meet quality

Position Qualifications:

  • Minimum of 8 years supervisory experience and 10 years’ experience in biologics/Gene Vector manufacturing is required.
  • Direct experience in gene/cell therapy manufacturing
  • Has a thorough understanding of cGMP requirements
  • Experienced in commercial manufacturing requirements for biological or cell or gene therapy
  • Excellent communication skills, both oral and
  • Demonstrated leadership
  • Ability to evaluate technical data and write technical