Quality Control
Samsung Biologics•Rockville, MD
•$67,072 - $89,430•Onsite
About The Position
Samsung Biologics is seeking a QC Bioanalytical Senior Associate Analyst to perform cell-based bioassays and immunoassays in support of testing biopharmaceutical raw materials, in-process samples, and drug substance under cGMP conditions. This role utilizes analytical techniques including ELISA, SDS-PAGE, Western blot, qPCR, cIEF, and Biacore. Additional responsibilities include cell culture, equipment management, general laboratory support, training of junior analysts, and coordination of routine laboratory activities.
Requirements
- Bachelor’s degree in a scientific discipline (e.g., Biology, Biochemistry, Chemistry, or related field)
Responsibilities
- Perform and document routine testing in compliance with cGMP requirements, including: Potency testing of drug substance and drug product for release and stability, Potency comparability and non-GMP studies, Testing of manufacturing growth media components for raw material release
- Execute analytical methods, including: qPCR (e.g., Minute Virus of Mouse detection), ELISA (identity, residual host cell protein, residual DNA, residual Protein A), cIEF (identity testing), Biacore (identity and binding analysis), SDS-PAGE and Western blot (identity and purity)
- Assist with assay development, optimization, and lifecycle activities as needed
- Method validation and transfer
- Critical reagent qualification
- Laboratory investigations and assay troubleshooting
- Operate, maintain, and troubleshoot QC laboratory equipment in a cGMP-compliant manner
- Execute routine assignments in accordance with approved procedures, escalating issues as appropriate
- Ensure compliance with safety, cGMP, CFR, and company policies through routine lab operations and safety checks
- Review laboratory SOPs and recommend improvements to ensure compliance with regulatory and corporate standards
- Revise SOPs and work instructions as assigned
- Participate in on-call response for environmental/chamber excursions, as required
- Support department self-inspections and may train as a Self-Inspector Auditor
- Assist with reference standard preparation/fills
- Train and mentor junior analysts
Benefits
- 13 paid holidays
- Vacation time
- 401K match
- Medical, dental and vision benefits effective day one of employment
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What This Job Offers
Job Type
Full-time
Career Level
Senior
