QC Associate Scientist, Microbiology (SHIFT LEAD)
Company: AGC Biologics
Posted on: January 7, 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. 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
We are currently looking for a Quality Control Microbiology
Associate Scientist (Shift Lead) to join the AGC Biologics team.
This position will provide technical and compliance leadership
related to microbiological assays, environmental monitoring,
facility qualification, and GMP quality systems within the Quality
Control department. The individual in this role will also review
data, author reports, and support laboratory instrument validation
as required. The ideal candidate will have extensive experience in
biopharmaceutical microbiology, GMP compliance, environmental and
utility monitoring, and strong organizational skills. This position
will oversee QC analysts as a team lead or supervisor. Experience
in a GMP Microbiology laboratory is preferred. This may be a Sunday
through Wednesday or a Wednesday through Saturday (4- 10 hour) Day
Complete microbiology and environmental monitoring assays,
including bioburden, endotoxin, conductivity and total organic
Perform and oversee product and facility testing related to
microbiological assays, review data and interpret and report
May perform sampling of water for injection, air, clean steam,
compressed gas and facility surfaces/air in ISO classified
Support projects / initiatives / team goals by delivering on all
Perform data verification and data entry.
Seeks opportunities for continual learning and improvement.
Participate in test method transfers and assay validations.
Act as subject matter expert on microbiological assays, method
qualification, technical troubleshooting, and instrument
Support onboarding and qualification of laboratory equipment and
GMP software systems.
Assist with the generation of SOPs related to test methods and
Assist in drafting technical documents including test methods,
validation documents, and deviations.
Implement change controls, lead investigations, and complete CAPAs
in support of GMP operations.
This position will support preparation of quarterly and annual
reports, trend investigations, statements of quality, and other
Serve as a trainer for Junior Analysts
Serve as a Subject Matter Expert on a particular method, program or
Represent QC Microbiology on cross-functional teams and prepare and
present data to internal and external clients.
This position will support and provide oversight of laboratory
analysts and laboratory analyses, testing logistics, data review,
and mentoring and coaching of lab analysts.
Knowledge, Skills & Abilities
Requires knowledge of environmental and utility monitoring
programs, compendial microbiological testing (Bioburden, Endotoxin)
and testing of water for injection.
Experience working in a GMP laboratory.
Strong organizational skills in a high-throughput environment.
Excellent communication with clear and concise writing & verbal
Ability to interact well in a team environment
Demonstrated organizational skills and attention to detail.
Ability to lift 50 lbs.
Education: Minimum BS in Biology, Microbiology, or other scientific
Minimum of 10+ years hands-on experience in a GMP QC Laboratory
Strong understanding of Microbiology related to drug substance or
drug product manufacturing.
Experience with relevant analytical laboratory equipment and
Experience with GMP biologics manufacturing and related regulatory
requirements including USP and EP compendial testing.
$85,000 - $108,000 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 , QC Associate Scientist, Microbiology (SHIFT LEAD), Other , Boulder, Colorado
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