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Senior Director to Executive Director, Global Process Development ( Cell/Gene Therapy) — Wuxi AppTec, Wuxi, China

Job ID 2019-5458

Overview

In the short-to-medium term the priorities of these two senior directors or executive directors Global Process Development are to:

  • Report to VP, Global Process Engineering and help to build each Global Process Development team in China of 10 staff this year which could grow rapidly over time
  • Work with US colleagues on platforms already under development for AAV and Lenti
  • Further grow the China Process & Technology Development organization, in a manner that is well coordinated with the Process & Technology Development (US) organization, for future technologies

Working location: Wuxi, China

Responsibilities

Key responsibilities:

  • Under the leader of VP of Global Process Engineering, co-development of global platforms, along with the US Product Development organization, with current focus on 3D platforms and viral vectors for the Advanced Therapies business: 
  • Partner with US Product Development, to develop platforms of cell lines and different manufacturing processes that are reproducible and scalable
  • Build out their organizations and organization skills so that their Global Product Development teams can work directly with global customers
  • Co-Develop platforms that can be licensed to customers for royalties and milestone payments
  • Participate in the development of global platforms and vector platforms that provide commercial scale production to customers, and more cost effective production for customers
  • Co-Develop platforms for cell or gene therapies, and produce cell lines where appropriate
  • Participate in the development of other key platforms in this area
  • Attend scientific conferences and represent WuXi to potential clients
  • Remain current on technologies to help maintain the organization’s long-term competitive position and profitability

Qualifications

Essential:

  • Ph.D. in pharmaceutical sciences, or a related field 
  • Experienced in viral and non-viral gene therapy product Process Development
  • Strong knowledge of cell culture techniques, gene therapy or cell therapy
  • Demonstrable evidence of building, developing and implementing Process Development systems in a systematic way
  • Experience of building and leading a group of senior scientists in Process Development
  • Technical Leader experience in multiple disciplines of science for Pharma and/or CRO business
  • Deep experience in bioreactors and cell line development 
  • Ability to build up quality yield from the upstream process
  • Fluent in English and Mandarin

Preferred:

  • Second line management experience 
  • Expertise in the field of vectors and/or vaccines

Key Attributes:

  • Able to work on multiple projects
  • Leadership  
  • Relationship building
  • Business acumen
  • Ability to influence in a matrixed environment

THE COMPANY

WuXi Advanced Therapies – Company Overview

The Advanced Therapies business unit of WuXi AppTec is a global Contract Development and Manufacturing Organization (CDMO) dedicated to accelerating and transforming development, manufacturing, and commercialization of cell, gene, and other advanced biopharmaceuticals.

Through continued internal reinvestment in facilities, technology, and talent combined with over three decades of biopharmaceutical testing expertise, WuXi Advanced Therapies have transformed their services for cell and gene therapy companies into solutions that alleviate industry bottlenecks, accelerate time to market, and support commercial programs around the world.

Serving clients that range from startup’s recently spun out of academic institutions, to large pharma companies seeking to launch a product in new markets, WuXi Advanced Therapies integrated development, manufacturing, and testing services provide tailored services that are ideal for:

  • Viral and non-viral Gene Therapies
  • Autologous and Allogeneic Cell Therapies
  • Gene Mediated and non-gene mediated Cell Therapies
  • Emerging technologies in cell gene therapy field like CRISPR/Cas9, NK cell, and Exosomes

ED/VP, global process development — WuXi AppTec, Shanghai, China

Job ID 2019-4767

Overview

  • Responsible for co-developing global platforms with US PD organization with a current focus on 3D platforms and viral vectors for our Advanced Therapies business.
    • Current key areas of focus our bioreactors and cell line development
    • Current focus on developing AAV and lenti platforms
    • Leads team to implement these platforms
  • Partners with US PD and the VP of Process and Technology Development in the US
  • Build out organization and organization skills so Global PD team can work directly with global customers.
  • Attend scientific conferences and represents WuXi to potential clients where appropriate.
  • Stays current on technologies to help maintain the organization’s long-term competitive position and profitability. 

Working location: Shanghai, China

Responsibilities

  • Responsible for developing AAV platforms that can be licensed to customers for royalties and milestone payments
  • Responsible for helping to develop global 3D platforms and vector platforms that will help us provide commercial scale production to customers, and more cost effective production for customers. 
  • Responsible for developing bioreactors platforms for cell and gene therapies, and producer cell lines where appropriate.
  • Responsible for helping to develop other key platforms in this area
  • Responsible for building strong PD team that can do PD work directly with global customers

Qualifications

  • Ph.D. in science discipline with a total of 20+ years of experience 
  • Senior Management level experience
  • Senior Technical Leader in multiple disciplines of science for the Pharma / CRO business
  • Deep experience in bioreactors and cell line development.  Experience with vectors or vaccines preferred
  • Excellent communication skills in both English and Chinese.

Equal Opportunity Employer Minorities/Women/Veterans/Disabled

2019 Advanced Course on Pharmaceutical R & D

SAPA-GP, partnering with Drexel, is offering our 3rd annual training course on the pharmaceutical R&D value stream. Delivered by industry executives and veterans, this one day course offers a birdview of key insights and steps of bringing an innovative drug from concept to commercialization. Participants from academic researchers, industry players, business investors, and service providers are welcome. Please visit us at https://sapa-gp.org and contact Yixuan Qiu ([email protected]) for additional information (this event includes breakfast, lunch, coffee breaks, and parking in Drexel).

Notice to SAPA-GP Members

Dear Members,

After the election on 5/31, SAPA-GP’s Senior Leadership Team (SLT) received reports on some voting irregularities, which are not compatible with the related rules of the association. As a result, the election results were invalid. To our best knowledge, neither candidate was involved in the irregularities. 

The Senior Leadership Team commits to improving the voting process so this doesn’t happen again. The SLT also apologizes to both candidates and any anguish this caused. We appreciate their understanding and courage in dealing with this difficult situation.  The SLT is working with both candidates to identify a solution. Both candidates are highly dedicated to SAPA-GP and their contributions are valued highly.  

Sincerely,
SAPA-GP SLT

Multiple positions — HJB

Position 1: Manager of QC Physical& Chemical Lab
Location: Based in Hangzhou
Responsibilities:
 Responsible for organizing daily physical and chemical analysis and ensuring the accuracy and timeliness; drafting and reviewing SOP related to the physical and chemical methods and instrument operation as well as maintenance in various programs; sample testing, records review and deviation investigation and settlement; if necessary, drafting and reviewing the protocol for pharmacopoeia methods validation, and writing
and verifying the 3Q protocol of relevant equipment;
 Responsible for ensuring that the current testing methods in GMP factory conform to CHP, EP, and USP from the latest compendia standards (for method testing and product release); organizing and participating in the annual verification of public systems in the GMP facility, such as the water system for Pharmaceutical use ;
 Establish quality specifications for raw material and package materials used in the GMP facility; ensure the sampling method and approach are science based and reasonable, ensure testing and release of raw materials and package material based on business schedule;
 Daily compliance management and EHS management of the physical and chemical analysis group;
 Talent management in physical and chemical analysis group.

Qualifications:
 Education background in related field including pharmaceutical engineering, pharmaceutical analysis and biotechnology with a master's degree and 7 years of experience, or a bachelor degree and 10 years of experience in QC;
 Possess knowledge in physical and chemical analysis and familiar with the pharmaceutical water system and quality control of raw and auxiliary materials;
 Familiar with physical and chemical testing and analysis technology; familiar with or mastered in purity and concentration analysis technologies such as gas chromatography, titrator, TOC, infrared and ultraviolet spectrophotometer, and capable of processing, integrating and interpreting analysis results;
 Familiar with cGMP/GLP and ICH regulations;
 Good team player; relevant project and personnel management experience is preferred;
 Good English reading and writing skills; excellent English speaking is preferred

Submit your resume to: [email protected]

Position 2: Floor QA Manager
Location: Based in Hangzhou
Responsibilities:
 Review and approve quality system documents related to production;
 Review and approve master batch records;
 Review executed batch records and support batch disposition of drug substance product;
 Oversee critical operations during production;
 Participate in quality related incident and deviation investigation, follow up CAPA implementation and CAPA effectiveness;
 Participate in internal audit;
 Perform daily walkthrough in production areas;
 Participate technology transfer;
 Provide GMP training.
Qualifications:
 Bachelor degree or above in chemistry, biology, pharmacy or other related fields;
 8+ years of experience in the pharmaceutical industry that includes 2+ years of QA experience;
 Familiar with GMP regulations; FDA and EMA audit experience and professional background in biopharmaceutical and aseptic production are preferred;
 Good team player and communication skills in both Chinese and English;
 Mostly working in the air-conditioned office with weekend holiday as well as occasional business trips and overtime;
 Frequently used equipment and tools include computer, calculator, stationery, folders and long-distance calls.

Submit your resume to: [email protected]

Position 3: Principle / Senior Scientist, Bioassay/Bioanalytical Development
Location: Based in Hangzhou
Responsibilities:
 As a senior member of Analytical Sciences organization, be responsible for the overall development strategy for bioassays and other bioanalytical methods, under the guidance of AS Head.
 Develop and qualify bioanalytical methods (e.g. ELISA and cell-based bioassays, high molecular weight impurity assays, binding affinity assays) to ensure their suitability for the intended use and ability to meet ICH and country-specific regulations.
 Manage a project team for analytical development or lead an analytical technology platform
 Responsible for the establishment and monitoring of product quality standards in assigned clinical-stage drug development programs or commercial stage process transfer/improvement programs
 Responsible for compliance to all applicable Data Integrity and Good Development Practices requirements for assigned methods and/or projects
 Responsible for method transfer to HJB Quality Control, and method transfer to/from external laboratory testing functions, for assigned methods/projects
 As a key Subject Matter Expert (SME) for Bioassay/Bioanalytical methods, contribute to complex laboratory investigations for related methods and manufacturing deviations e.g. OOS/OOE results
 Responsible for continuous improvement of established methods and development of new technology-based bioanalytical methods
 Coaching/leading junior members to enhance team capabilities.
Qualifications:
 Advanced degree (Master, PhD is preferred) in Life Sciences, Biology, Biochemistry, Analytical Chemistry, Immunology, or related disciplines
 7+ years of relevant experience for Master degree holders; or 3+ years of relevant experience for PhD degree holders
 In-depth knowledge of large-molecule therapeutics in areas of biosynthesis, structure function, bioanalysis, monoclonal antibody mechanism of action (MoA), cell signaling
 Good knowledge in the modern analytical instrument in bioassay/bioanalytical applications.

Submit your resume to: [email protected]

Position 4: Senior Scientist/Principle Scientist, Purification, Process Development
Location: Based in Hangzhou
Responsibilities:
 Responsible for leading projects in protein purification process development under the supervision of the purification director.
 Lead a project team to design and execute experimental plans.
 Responsible for the development of a complete purification process to meet quality requirements on clinical and/or commercial production of biopharmaceuticals.
 Responsible for preparation of technical documents for regulatory filing of purification related sections.
 Develop novel technologies on protein separation and purification for continuous improvement.
Qualifications:
 Master's degree or above in biochemistry, molecular biology, chemistry,
bioengineering, pharmacy, biochemical engineering or other relevant fields.
 Master's degree with 7+ years’ experience or PhD with 3+ years of working experience in the industry with major in protein separation and purification.
 Strong analytical and problem-solving skills. Knowledge of the chemical properties of proteins and antibodies. Operational experience in various technologies and equipment for large-scale purification is preferred.
 Previous experiences in biomedical development projects that received clinical approval is preferred.

Submit your resume to: [email protected]

Position 5: Principal Scientist, Analytical Development
Location: Based in Hangzhou
Responsibility:
 As a senior member of Analytical Sciences organization, be responsible for the overall development strategy for analytical methods (separation sciences and advanced spectroscopy/spectrometry), under the guidance of AS Head.
 Develop and qualify analytical methods (e.g. HPLC- and CE-based purity/impurity methods, assay by UV, Multi-Attribute methods) to ensure their suitability for the intended use and ability to meet ICH and country-specific regulations.
 Manage a project team for analytical development or lead an analytical technology platform
 Responsible for the establishment and monitoring of product quality standards in assigned clinical-stage drug development programs or commercial stage process transfer/improvement programs
 Responsible for compliance to all applicable Data Integrity and Good Development Practices requirements for assigned methods and/or projects
 Responsible for method transfer to HJB Quality Control, and method transfer to/from external laboratory testing functions, for assigned methods/projects
 As a key Subject Matter Expert (SME) for Phys-Chem methods, contribute to complex laboratory investigations for related methods and manufacturing deviations e.g. OOS/OOE results
 Responsible for continuous improvement of established methods and development of new technology-based phys-chem analytical methods and/or characterization methods
 Coaching/leading junior members to enhance team capabilities
Qualifications:
 Advanced degree (Master, PhD is preferred) in Life Sciences, Biology, Biochemistry, Analytical Chemistry, Immunology, or related disciplines
 7+ years of relevant experience for Master degree holders; or 3+ years of relevant experience for PhD degree holders
 In-depth knowledge of large-molecule therapeutics in areas of biosynthesis, structurefunction, bioanalysis
 Good knowledge of modern analytical instrument for bioanalysis
 Experience in analytical method development/validation during large-molecule drug technical development; experience in leading analytical and/or CMC development project is highly preferred
 Rigorous, diligent, eager to learn and good team player; strong analytical and problem-solving skills;
 Highly proficient in spoken and written English and English-Chinese translation.

Submit your resume to: [email protected]

Position 6: Senior Scientist, Cell culture
Location: Based in Hangzhou
Responsibilities:
 Under the department technical director’s guidance, responsible for the R&D planning for cell culture process, process optimization and scale up of the entire project and gaining a deep understanding of the technical background and features of the project.
 Independently lead the R&D work at project level; analyze and solve problems;
 Optimize process to maximize product yield, meet process quality requirements and reduce cost to meet quality and approval standards of clinical and commercial production of the biomedical industry nationally;
 Responsible for the integrity and quality of the project, including documents, data and materials needed for obtaining approval of the process;
 Develop new and more productive cell culture process technology and make continuous improvement.
Qualifications:
 Degrees in biochemical engineering, fermentation engineering, bioengineering and other relevant fields;
 Candidate with master's degree should be accompanied with 5+ years of experience; or PhD focusing on metabolic research of cell culture for proteins and antibodies, and on nutritional requirements cell growth;
 Rigorous, diligent, eager to learn, good team player and good at communication;
 Strong analytical and problem-solving skills; possess in-depth knowledge of cell culture and metabolic pathways, and operational experience in various techniques and equipment for large-scale cell culture or fermentation;
 Previous experiences in biomedical development projects that received clinical approval is preferred;
 Highly proficient in spoken and written English and English-Chinese translation.

Submit your resume to: [email protected]

Boston Sales Manager — Sino Biological

Company Introduction:

Sino Biological is an internationally recognized reagent supplier and contract research organization. Sino Biological's core technology platform is its in-house developed mammalian cell-based recombinant expression system. The system employs a range of proprietary reagents and processes, enabling high-efficient production of antigens and antibodies. The company has developed a catalog of 10,000+ recombinant antigens from mammalian cells, E. Coli, and insect cells, along with 2,000+ novel clones of monoclonal antibodies through mouse hybridoma technology and rabbit phage display technology. Sino Biological also offers customized antigen and antibody development and expression services. The company has successfully completed hundreds of projects for research, therapeutic, and diagnostic antibody development.

Sino Biological’s manufacturing facility is in Beijing, China, while its US headquarter is in the greater Philadelphia area. The company is undergoing a major expansion. There are multiple positions available in Boston, Philadelphia, and Beijing.

Job title: Sales manager/associate (based on qualifications)

Report to both director of sales in the US
Salary range: based on qualifications
Bonus: Based on the overall sale number and performance
Location: Boston

Job Description:

The individual will be a member of the sales team. The primary responsibility is to sell products and services in the State of MA, mainly in the greater Boston area. The clients include pharmaceutical and biotech companies, CROs, clinical laboratories, and academic labs. The successful candidate is expected to increase the sales revenue in the territory. Specifically,

  • Sell products and services in the territory through customer facing visits, presentations, phone calls, and e-mails;
  • Work with the director of the sales to develop and execute a territory sales plan;
  • Provide technical support to the customers (manager only);
  • Work collaboratively with the Inside sales, Product Development team, and Marketing teams;
  • Attend tradeshows, both local and international, and networking events as necessary;

Requirement:

  • A master or Ph.D. degree from a biomedical discipline is preferred;
  • Have a good understanding of biologic research, drug discovery, and diagnostics field, and the relevant technologies, products, and services (manager only);
  • Relevant working experience is preferred but not required;
  • Ability to learn fast;
  • Willingness to learn new technologies;
  • Ability to work independently;
  • Strong Communication Skills;

Contact:

Please contact the hiring managers below:
Cory Lin: [email protected]
Sheila Wu: [email protected]

Product Manager — Sino Biological

Company Introduction:

Sino Biological is an internationally recognized reagent supplier and contract research organization. Sino Biological's core technology platform is its in-house developed mammalian cell-based recombinant expression system. The system employs a range of proprietary reagents and processes, enabling high-efficient production of antigens and antibodies. The company has developed a catalog of 10,000+ recombinant antigens from mammalian cells, E. Coli, and insect cells, along with 2,000+ novel clones of monoclonal antibodies through mouse hybridoma technology and rabbit phage display technology. Sino Biological also offers customized antigen and antibody development and expression services. The company has successfully completed hundreds of projects for research, therapeutic, and diagnostic antibody development.

Sino Biological’s manufacturing facility is in Beijing, China, while its US headquarter is in the greater Philadelphia area. The company is undergoing a major expansion both in the US and in China. There are multiple positions available in Boston, Philadelphia, and Beijing.

Job title: Product Manager

Salary range: based on qualifications
Bonus: Performance-based
Location: Beijing, China

Job Description:

The individual will be a member or the leader of the product management team. The primary responsibilities include market research, product planning and management, product marketing, and technical support. Specifically, the individual will be required to:

Product development functions:

  • Perform analysis to identify market opportunities, and develop product strategies and long-term roadmaps;
  • Work with the R&D dept. to form product development plans;
  • Work with the R&D dept. to set product specifications
  • Oversee product development
  • Determine pricing strategies

Marketing functions:

  • Develop marketing plans for products
  • Implement marketing plan in conjunction with all departments
  • Support sales and marketing with the necessary technical expertise
  • Conduct product presentations
  • Develop sales training material and marketing materials

Support functions:

  • Manage product-related support, feedback and inquiries from users
  • Monitor product inventory
  • Use market feedback to inform product refinements and ongoing development

Requirement:

  • A Ph.D. degree from a biomedical discipline;
  • Training experience in protein biochemistry, antibody development, and immunology is preferred;
  • Have a good understanding of biologic research, drug discovery, and diagnostics field, and the relevant technologies, products, and services (manager only);
  • Ability to learn fast;
  • Ability to multi-task;
  • Ability to work independently;
  • Strong Communication Skills;

Contact:

Please contact the hiring managers below:

Rachel Hu: [email protected]
Cory Lin:   [email protected]
Sheila Wu: [email protected]

Sales office manager — Sino Biological

Company Introduction:

Sino Biological is an internationally recognized reagent supplier and contract research organization. Sino Biological's core technology platform is its in-house developed mammalian cell-based recombinant expression system. The system employs a range of proprietary reagents and processes, enabling high-efficient production of antigens and antibodies. The company has developed a catalog of 10,000+ recombinant antigens from mammalian cells, E. Coli, and insect cells, along with 2,000+ novel clones of monoclonal antibodies through mouse hybridoma technology and rabbit phage display technology. Sino Biological also offers customized antigen and antibody development and expression services. The company has successfully completed hundreds of projects for research, therapeutic, and diagnostic antibody development.

Sino Biological’s manufacturing facility is in Beijing, China, while its US headquarter is in the greater Philadelphia area. The company is undergoing a major expansion. There are multiple positions available in Boston, Philadelphia, and Beijing.

Job title: Sales office manager

Report to both director of sales in the US, and the head of the customer service department in the HQ
Salary range: Based on qualification
Bonus: Based on the overall sale number and performance
Location: Philadelphia

Job Description:

The primary responsibilities for the sales office manager are to lead the customer service and inside sales team to improve the company’s customer interface (via online activities and phone calls), and to manage the day-to-day operation in the sales office. The ultimate goal is to enhance overall operational efficiency and customer experience. The successful candidate is expected to lead the team to:

  • 1) Provide courteous, efficient customer interface;
  • 2) Develop leads from inbound inquiries and close sales;
  • 3) Provide necessary support to the ground sales team;
  • 4) Manage day-to-day office operation (travel time less than 5% time);

Specifically,

  • Provide general correspondence, dealing with quotations, complaints, requests for information and other queries about orders from US customers; Engage and coordinate local salespersons and/or other relevant departments when necessary;
  • Distribution arrangements and arranging for the shipping, handling, and storage of goods;
  • Develop new sales opportunities through inbound inquiry/lead follow-up, and close sales if necessary;
  • Research and manage account activities and identify key potential targets;
  • Maintain and expand the database of prospects;
  • Sales statistics;

Requirement:

  • A master or Ph.D. degree from a biomedical discipline is preferred;
  • Relevant working experience is preferred but not required;
  • Ability to learn fast;
  • Ability to work independently;
  • Strong Communication Skills;

Contact:

Please contact the hiring managers below:

Cory Lin: [email protected]; Sheila Wu: [email protected]