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 Sr. Manager will provide leadership for Product Lead Team within Quality Control. This position will provide direction for development, execution and monitoring of product portfolio and delivering timelines throughout a product’s lifecycle within Quality Control. Additionally, the position will engage with customers and promote a positive customer centric experience. The ideal candidate will be an expert in customer relations, laboratory compliance and developing interdepartmental relationships.
- Oversee QC Product Representative Team and provide organizational direction
- Provide subject matter expertise on Method Transfer, Method Qualification and Validation
- Provide subject matter expertise supporting timely closure of deviations, CAPAs and Change Controls required for product advancement
- Engage with external clients providing first-class customer experience
- Develop with a continuous improvement mindset meaningful metrics for the team
- Drive continuous improvement to related processes
- Ensure on-time support of product lifecycle requirements including manufacturing operations
- Develop and coach staff in alignment with company goals and individual career aspirations
KNOWLEDGE, SKILLS & ABILITIES:
- Extensive experience with Analytical and Microbiological Techniques
- 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.
- BS/BA degree with 12+ 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.
- 7-10+ years of experience managing a team.
$129,500 - $170,940
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