Senior Manager, QC Microbiology
Company: AGC Biologics
Posted on: August 1, 2022
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 Sr. Manager, QC Microbiology will provide leadership for GMP
analytical testing for clinical and commercial products. In
addition, this position will provide direction for method
qualification, technology transfer activities, and specification
setting associated with QC testing of the Company's GMP products.
The ideal candidate will be an expert in technical problem-solving
and developing interdepartmental relationships.
- Lead and manage activities of the Quality Control microbiology
lab personnel and ensure the efficiency and effectiveness of
activities related to environmental monitoring, in-process and drug
substance lot release testing, new product introduction and product
changeover, and cleaning validation studies.
- Assist in the design, implementation and continuous improvement
of Quality Control systems that are technically sound, promote
effective and efficient operations, and comply with cGMP
- Overseeing laboratory investigations, deviations, CAPAs and
- Responsible for site Periodic and Routine Environmental
- Represent QC on teams and prepare and present data to internal
and external clients.
- Hire, mentor and develop exceptional QC personnel.
- Provide knowledge and understanding of overall maintenance,
calibration, and qualification of the QC laboratory analytical
- Act as subject matter expert for QC GMP operations during
audits and regulatory inspections. Maintain QC microbiological
laboratories and facilities in audit and inspection readiness
Knowledge, Skills & 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.
- Minimum BS, but preferably an advanced degree in Microbiology
or other Biological Science.
- Minimum of 12+ years hands-on experience with Quality Control
Microbiology testing, such as environmental monitoring, bioburden
and endotoxin, in a regulated environment (GMP, GLP, etc.).
- 5+ years of people management experience coaching employees in
day-to-day performance, goal setting and career development.
- Experience with relevant analytical laboratory equipment and
- Equivalent education and experience may substitute for stated
$129,500 - $155,400 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
Keywords: AGC Biologics, Boulder , Senior Manager, QC Microbiology, Executive , Boulder, Colorado
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