Quality Control
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.
Key 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
Additional Responsibilities
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
Education:
Bachelor’s degree in a scientific discipline (e.g., Biology, Biochemistry, Chemistry, or related field)
The anticipated salary range for this position in Maryland is $67,072 to $89,430 plus annual bonus, when eligible. The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc.
Benefits:
· 13 paid holidays
· Vacation time
· 401K match
· Medical, dental and vision benefits effective day one of employment