QC Scientist I, Biochemistry
Company: AGC Biologics
Location: Boulder
Posted on: June 20, 2022
Job Description:
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
www.agcbio.com.SummaryThe Quality Control Scientist I -
Biochemistry will perform routine and more complex tasks in the
Quality Control laboratory, including testing of in-process,
release, and stability samples, execution of method transfer and
validation studies, and instrument qualification. The ideal
candidate will have extensive experience in a GMP laboratory,
strong technical writing skills, and proficiency with HPLC, CE-SDS,
ELISA and other biopharmaceutical analytical techniques.Key
Responsibilies
- Perform in-process, release and stability testing of
biopharmaceutical test samples in a GMP QC laboratory using a wide
variety of technologies, including HPLC/UPLC, capillary
electrophoresis (CE-SDS and icIEF), ELISA, and cell-based
bioassays.
- Execute method transfer and validation studies, develop data
processing and report templates, and troubleshoot assays and
instruments.
- Author, review and approve test methods, procedures,
specifications, and validation documents.
- Assist in the onboarding and qualification of new laboratory
instruments. Author user requirement specifications, IOQ protocols,
data integrity risk assessments, and operation and maintenance
- Mentor and train analysts on test methods and laboratory
procedures, good documentation practices, data review, and other QC
quality systems.
- Lead change controls, investigations, and CAPAs in support of
GMP operations. Drive Quality deliverables to closure by agreed
upon due dates.
- Represent QC during client audits and regulatory inspections.
Maintain the QC laboratory in an inspection ready state.Knowledge,
Skills & Abilities
- Extensive experience with biopharmaceutical analytical
techniques such as HPLC, CE-SDS, ELISA, bioassay, and/or compendial
testing.
- Experience with GMP laboratory data systems, including LIMS,
Empower, SoftMax Pro, or other analytical systems.
- Knowledge of FDA and ICH requirements for method transfer,
validation, data integrity, and compendial verification.
- Demonstrated ability to work effectively on cross-functional
teams, including with Analytical Development, Quality Assurance,
Manufacturing, and Validation personnel.
- Strong organizational and project management skills, including
technical writing and presentation of technical
data.Education/Experience
- Education: Minimum BS in Biochemistry, Biology or other
scientific discipline
- Experience: Minimum of 5+ years in a GMP laboratory
environment, preferably in the biopharmaceutical industry.
- Trained in fundamental GMP quality systems, including good
documentation practices, data integrity, change management, and
laboratory controls.
- Experience with the design, operation, validation, and
maintenance of complex laboratory equipment and software
systems.Compensation Range$87,417 - $104,900 annuallyAGC 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.
Keywords: AGC Biologics, Boulder , QC Scientist I, Biochemistry, Other , Boulder, Colorado
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