QC Manager, Bioassay
Company: Agc Biologics
Posted on: January 16, 2022
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 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
- Oversee bioassay and immunoassay testing and provide training
- Provide subject matter expertise during internal and regulatory
- Author test method, guidance documents, and other SOPs
- Provide technical support during analytical method transfer
- Oversee laboratory investigations, deviations, and CAPAs
- Ensure testing commitments are scheduled and adhered to per
- 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
- 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
Keywords: Agc Biologics, Seattle , QC Manager, Bioassay, Executive , Seattle, Washington
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