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: This is a Director, Quality Control position in the Quality Control group. Primary responsibilities include leading all aspects of a Quality Control department, hiring and developing management level staff, providing strategic decision making consistent with department and organizational goals, and ensuring cGMP compliance throughout Quality Control laboratories and operations. Additional responsibilities include oversight of QC budget and resources, leadership of cross-functional teams, and support for client audits and regulatory inspections.
- Ensure compliance and business deliverables are met
- Make strategic department and project decisions
- Forecast and manage resources and budget needs
- Oversee on-time-delivery of raw materials, in-process samples, and Bulk Drug Substance
- Establish key metrics to determine department performance
- Provide mentoring and career development to employees
- Oversee QC regulatory compliance and manage efficiency of operations and continuous improvement activities
- Provide expert technical analysis and evaluation of Quality Control issues impacting AGC Biologics projects
- Interact with clients during CDMO selection and throughout projects for problem solving
KNOWLEDGE, SKILLS AND ABILITIES:
- Ability to direct a 24 X 7 Quality Control laboratory operation including management and technical employees
- Ability to manage department budget and resources
- Ability to work in a highly dynamic environment including working with and through others to accomplish goals
- Knowledge/expertise in mammalian cell testing including instrumentation, analytical method transfers, and analytical method validation
- Knowledge of microbiological and environmental monitoring methods and practices for a low- bioburden facility
- Experience in leading change management efforts in support of a growing and dynamic business
- Experience participating in regulatory inspections
- Experience in all aspects of GMP QC laboratory management
- Knowledge of US and EU regulatory requirements with respect to Quality Control
- Ability to solve technical/quality analytical problems
- Expertise in the development of product specifications and stability studies, including the review and approval of analytical test results, controlled documents, and validation protocols/reports.
- Strong interpersonal, written and oral communication skills
- BS or MS in life science or chemistry required
- Minimum of 12 years of experience in a FDA-regulated pharmaceutical environment performing QC functions with a Bachelor’s degree
- Minimum of 8 years management experience in a GMP Quality Control laboratory
- Equivalent education and experience may substitute for stated requirements.
$171,250 - $205,500 annually
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