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.