Career Opportunities: Senior Manager, Quality Control (1803) at Wuxi Biologics in Cranbury, New Jersey

Posted in Executive 9 days ago.

Job Description:

Wuxi Biologics

Requisition ID: 1803
Location: Cranbury, NJ


WuXi Biologics (stock code: 2269.HK), a Hong Kong-listed company, is a leading global open-access biologics technology platform offering end-to-end solutions to empower organizations to discover, develop and manufacture biologics from concept to commercial manufacturing. Our company history and achievements demonstrate our commitment to providing a truly ONE-stop service offering and strong value proposition to our global clients. As of December 31, 2018, there were a total of 205 integrated projects, including 97 projects in pre-clinical development stage, 94 projects in early-phase (phase I and II) clinical development, 13 projects in late-phase (phase III) development and 1 project in commercial manufacturing. With total estimated capacity of biopharmaceutical production planned in China, Ireland, Singapore and US reaching 220,000 liters by 2022, we will provide our bio manufacturing partners with a robust and premier-quality global supply chain network.

Job Summary

Lead all aspects of microbial Quality Control in support of bio therapeutic product manufacturing. Manage environmental and utility programs and microbiological testing. Play a key role in supporting the manufacturing plant's contamination control strategy and serve as the technical lead for evaluating, validating, and implementing microbiology methods.

Manage and schedule analysts to perform job functions. Oversee EM and Micro laboratory data, final report, and lab operation. Responsible for the quality and on-time delivery of test results, validation data, and all other QC deliverables to internal and external clients.

Demonstrate strong oral and written communication skills and actively contribute to training, report generation, and documentation.

Demonstrate strong supervisory skills and contributes to the achievement of company and departmental goals and objectives.

Essential Job Functions
  • In charge of QC EM and Micro team which covers the environmental monitoring testing program and microbiological testing for raw material, in-process and release samples.
  • Manage environmental monitoring and site contamination control programs, including EM risk assessment, testing, trending, interpretation of EM data, and oversight of the EM excursion business process. Lead investigations and/or change control strategies for processes that impact environmental control.
  • Work closely with stakeholders in manufacturing, engineering, and validation to drive alignment to site contamination control goals and standards.
  • Responsible for establishing the microbiology testing function.
  • Serve as a key member of the Quality organization and subject matter expert on microbiological assays and new technology.
  • Provides key input and recommendation of data review or investigation process. Serves as lead for client discussions regarding project quality or investigations/nonconformances as they relate to studies.
  • Conduct and direct assays and lab procedures according to and in compliance with GLP, cGMP, CFR and/or PTC guidelines and SOPs.
  • Provide training on areas of technical expertise and compliance issues relevant to the Micro Biology Lab.
  • Author, review, and approve SOPs, validation protocols, investigations, specifications, and related documents. Closely work with staff members to initiate Microbiology deviations, CAPA, OOS, and OOL investigations.
  • Provides operational, technical, and administrative leadership to the Microbiology Department through supervision and planning.
  • Supervise, plan, and review operations for assigned staff members, including responsibilities for training, managing, and evaluating, as well as coordinating, scheduling, and assigning work. Plan and budget for Lab personnel, supplies, and equipment resources.
  • Closely work with internal and external stakeholders to assure that the appropriate information is effectively communicated and documented.

  • Minimum Bachelor of Science degree and/or advanced Graduate degree in Chemistry, Microbiology, Biochemistry or equivalent field.
  • 10+ years of relevant experience or equivalent for Bachelors', 8+ years for Master's in the Quality Control or related field or equivalent experience.
  • 5+ years' supervisory responsibilities in Pharmaceutical industry with emphasis in aseptic processing, QC microbiology, environmental monitoring, water systems, cGMP, and validation.
  • In-depth knowledge of microbial contamination control, microbiological methods and demonstrated capability in using that knowledge to provide Quality leadership to all aspect of microbiology.
  • Subject matter expertise and hands-on proficiency with all aspects of pharmaceutical microbial control.
  • Hands-on experience with microbiological methods such as Bacteriostasis and Fungistasis, endotoxin testing, bioburden and sterility testing.
  • Experience and extensive understanding of environmental control regulations and guidelines with in-depth understanding of cGMPs.

The job description does not intend to list all the duties and responsibilities assigned to this position. Employee holding this position would be required to perform other job-related duties/responsibilities based on their expertise and company business needs.

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
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Equal Employment Opportunity/M/F/disability/protected veteran status PI138893458