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