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QC Sr. Manager, Biochemistry

Company: Agc Biologics
Location: Boulder
Posted on: January 12, 2022

Job Description:

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 and cell and gene therapies. 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

We are currently looking for a Quality Control Manager (Biochemistry) to join the AGC Biologics team. This is an exciting opportunity to provide leadership for GMP analytical testing for clinical and commercial products. This position will provide direction for method validation and transfer activities, oversee in-process, release, and stability testing, recruit and mentor staff, and lead continuous improvement in the QC laboratory. The ideal candidate will be an expert in technical problem-solving and developing interdepartmental relationships.

Key Responsibilies

  • Lead and manage activities of the Quality Control Biochemistry lab personnel and ensure the efficiency and effectiveness of activities related to in-process and lot release testing, stability testing, analytical method transfer, and analytical method validation.
  • As a member of the QC leadership team, assist in the design, implementation and continuous improvement of Quality Control systems that are technically sound, promote effective and efficient operations, and comply with cGMP requirements.
  • Represent QC on cross-functional teams and prepare and present data to internal and external clients.
  • Oversee laboratory investigations, deviations, CAPAs and technical troubleshooting
  • Ensure QC deliverables, including release and stability data, method transfer and validation studies, and other GMP activities, are consistently completed within agreed upon turnaround times.
  • Hire, mentor and develop exceptional QC personnel.
  • Provide knowledge and understanding of overall maintenance, calibration, and qualification of the QC laboratory analytical equipment.
  • Act as subject matter expert for QC GMP operations during audits and regulatory inspections. Maintain QC laboratories and facilities in audit and inspection readiness mode.
    Knowledge, Skills & Abilities
    • Ability to understand analytical/technical data.
    • Clear, concise writing skills.
    • Good organizational skills and attention to detail.
    • Ability to interact constructively with co-workers.
      Education/Experience
      • Education: Minimum BS, but preferably an advanced degree in Biochemistry, Chemistry or other scientific discipline
      • Experience: Minimum of 10+ years hands-on experience with Quality Control Biochemistry testing, such as UPLC, ELISA, CE-SDS, and bioassay testing in a regulated environment (GMP, GLP, etc.)
      • 5+ years of people management experience coaching employees in day-to-day performance, goal setting and career development
      • Experience with relevant analytical laboratory equipment and software
        Compensation Range

        $121,850 - $ 159,600

        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.
        • 1
          by Jobble

Keywords: Agc Biologics, Boulder , QC Sr. Manager, Biochemistry, Executive , Boulder, Colorado

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