QC Manager, Bioassay

Company: Agc Biologics
Location: Seattle
Posted on: January 16, 2022

Job Description:

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 Quality Control Manager will provide leadership for GMP analytical testing for clinical and commercial products. This position will provide direction for bioassay and immunoassay testing, organization, and associated quality systems within the Quality Control department. The ideal candidate will be an expert in laboratory compliance and developing interdepartmental relationships.

Principal Responsibilities

• Oversee bioassay and immunoassay testing and provide training to staff
• Provide subject matter expertise during internal and regulatory agency inspections
• Author test method, guidance documents, and other SOPs
• Provide technical support during analytical method transfer into QC
• Oversee laboratory investigations, deviations, and CAPAs
• Ensure testing commitments are scheduled and adhered to per clients requirements
• Ensure functional area equipment lifecycle is managed to prevent disruption of analytical testing
• Perform final review of QC in process, release, and stability data for drug substance and drug product
• Develop and coach staff in alignment with company goals and individual career aspirations
  Knowledge, Skills And 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 Microbiology, Biochemistry or other Biological Science.
    • Extensive experience with GMP bioassay and immunoassay instruments, including plate readers (i.e. Spectramax, i3X, Enspire), incubators, and controlled temperature units
    • Detailed understanding of data integrity requirements for GMP operations, including 21CFR Part 11 and GAMP 5.
    • Demonstrated ability to work effectively on cross-functional teams
    • Strong organizational and project management skills, including technical writing and presentation of technical data
    • 5+ years of people management experience coaching employees in day-to-day performance, goal setting and career development
      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.by Jobble

Keywords: Agc Biologics, Seattle , QC Manager, Bioassay, Executive , Seattle, Washington