Looking for an experienced QC biochemist to continue growing their career in downstream/upstream manufacturing. This role will be with our client who has a global footprint in both R D and manufacturing within the biopharma industry.
Perform analytical testing to support product in-process, release, and stability programs.
Demonstrate strong knowledge of cGMP, Quality Systems, and ICH/regulatory guidance.
Conduct, compile, and/or review Out of Specification (OOS) lab investigations, deviations, and corrective and preventative action plans.
Collaborate with cross-functional teams to advance projects, maintain equipment, and author documents and reports.
Train other analysts in laboratory procedures and assays.
Participate in internal assessments and audits as required.
Perform other functions as assigned.
Comply with all company policies and standards.
Bachelor's degree in biotechnology, biochemistry, chemistry, or related field with a minimum of 5 years of experience in a pharmaceutical/biotech QC laboratory.
Alternatively, a Master's degree in the above fields with 3 years of experience in a pharmaceutical/biotech QC laboratory or a PhD with a minimum of 2 years of experience.
Previous experience in a cGMP laboratory.
Strong background in protein chemistry and experience troubleshooting analytical results.
Demonstrated success in writing, revising, and complying with SOPs, protocols/reports, and QC methods.
Demonstrated expertise with techniques such as HPLC, SDS-PAGE, cell-based bioassays, capillary electrophoresis, ELISA, and standard compendial assays.