AGC Biologics is a leading global Contract Development and Manufacturing Organization, with a deep commitment to improving life quality by bringing new biopharmaceuticals to market. Because of our dedication to building and empowering our internal teams, AGC Biologics is an innovative leader in the industry with an extensive network of cGMP facilities in the US, Europe and Asia. As such, we deliver a deep expertise, dynamic solutions and technologies, as well as customized services for the scale-up and cGMP manufacturing of protein-based therapeutics. We forge exceptionally strong partnerships with our clients, and we never lose sight of our pledge to deliver a reliable and compliant drug substance supply. Right. On time. For more information, visit www.agcbio.com .

SUMMARY:

The Senior Manager of Quality Control will provide leadership for Microbiology testing management within Quality Control. This position will provide direction for environmental and utility monitoring, in-process and drug substance release testing within Quality Control. Additionally, the position will oversee continuous improvement initiatives and alignment with other sites.  The ideal candidate will be an expert in laboratory compliance and developing interdepartmental relationships.

PRINCIPAL RESPONSIBILITIES:

  • Oversee QC Microbiology team and provide organizational direction.
  • Provide subject matter expertise on microbiology testing technologies.
  • Oversee organization’s laboratory investigations, deviations, and CAPAs.
  • Drive continuous improvement to related processes.
  • Drive harmonization of practices for shared products among AGC sites.
  • Ensure on-time support of manufacturing operations.
  • Develop and coach staff in alignment with company goals and individual career aspirations.

KNOWLEDGE, SKILLS & ABILITIES:

  • Extensive experience with Microbiology Technologies.
  • Extensive experience with Quality Systems and Regulatory Inspections.
  • Extensive experience with metric development, monitoring and improvement.
  • Detailed understanding of data integrity requirements for GMP operations, including 21CFR Part 11.
  • Demonstrated ability to work effectively on cross-functional teams and engage with external clients.
  • Strong organizational and project management skills, including technical writing and presentation of technical data.

EDUCATION/EXPERIENCE:

  • BS/BA degree with 10+ years of industry experience,
  • Master’s degree with 10+ years of industry experience, or
  • PhD with 7+ years of industry experience. Equivalent education and experience may substitute for stated requirements.
  • Extensive previous managerial experience also required.

 

AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances

 

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