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.
The Quality Control Manager - Raw Materials will provide leadership in a Quality Control laboratory supporting GMP manufacturing of clinical and commercial products. This position will develop and implement the QC raw materials program, including receipt, sampling, testing, and associated quality systems within the Quality Control department. The ideal candidate will be an expert in GMP raw material programs, including vendor management, compendial and non-compendial release testing, and product disposition.
- Lead and manage activities of QC laboratory staff to ensure the completion of sampling, testing, and data review activities within agreed upon turnaround times.
- Establish the strategy, workflows, and KPIs required to complete raw material testing and release activities in an efficient and GMP compliant manner.
- Act as a subject matter expert for raw material specifications, vendor qualification, testing activities, and GMP compliance within the QC raw material laboratory.
- Author, review, and approve procedures for raw material sampling, chain of custody, data management, lot disposition, and related quality systems.
- Oversee laboratory investigations, deviations, CAPAs and technical troubleshooting for in-house and contract testing laboratories.
- Work closely with Quality Assurance, Manufacturing, Supply Chain, and other internal and external customers to ensure that QC deliverables are completed on time and meet AGC quality standards.
- Hire, mentor and develop exceptional QC personnel.
- Represent QC during audits and regulatory inspections. Maintain QC laboratories and facilities in audit and inspection readiness mode.
KNOWLEDGE, SKILLS & ABILITIES:
- In depth knowledge of regulatory requirements for raw materials used in GMP manufacturing.
- Experience in a high-throughput GMP laboratory environment.
- Ability to work constructively across groups and departments.
- Good organizational skills and attention to detail.
- Education: Minimum BS in Biology, Biochemistry or other scientific discipline.
- Experience: Minimum of 8+ years hands-on experience in a GMP laboratory or manufacturing environment.
- Experience: Minimum 5+ years managing, training and coaching employees in day-to-day performance, goal setting and career development.
- Experience managing suppliers and/or contract testing laboratories. Auditing experience preferred.
$101,330 - $130,720 per year
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.