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:

The Manager/Sr. Manager, QC Biochemistry will provide leadership for GMP analytical testing for clinical and commercial products. In addition this position will provide direction for method validation, transfer activities and specification setting associated with QC testing of the Company’s GMP products. The ideal candidate will be an expert in technical problem-solving and developing interdepartmental relationships.

 

PRINCIPAL RESPONSIBILITIES:

  • Lead and manage activities of the Quality Control Biochemistry lab personnel and ensure the efficiency and effectiveness of activities related to raw materials, in-process, and drug substance lot release testing, stability testing, analytical method transfer, and analytical method validation.
  • 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.
  • Oversee laboratory investigations, deviations, CAPAs and 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.
  • Represent QC on cross-functional teams and prepare and present data to internal and external clients.
  • 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 HPLC, ELISA, Bioassay, and CE-SDS 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.
  • Equivalent education and experience may substitute for stated requirements.

 

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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