QC Analyst III -Chromatography
About The Position
The QC Analyst III is responsible for analytical testing and data verification supporting late-stage clinical and commercial small molecule and biosimilar products in cGMP-compliant laboratories. The role requires a strong background in protein chemistry to perform and troubleshoot analytical techniques and assays, including HPLC, SDS-PAGE, cell-based bioassays, capillary electrophoresis, ELISA, and standard compendial assays. The analyst collaborates across departments to resolve projects and laboratory investigations promptly and to support process improvements. The position is onsite five days a week, 9:00 AM to 5:30 PM EST. The work includes laboratory and plant-auditing activities in manufacturing clean rooms, with possible brief or minimal exposure to hazardous chemicals and work around hazardous equipment and conditions. Personal protective equipment is required where appropriate. Flexible hours may be needed, and the role requires working under pressure and meeting deadlines. There is no supervisory responsibility.
Requirements
- Bachelor’s degree in biotechnology, biochemistry, chemistry, or a related field.
- Five or more years of experience in a cGMP biologics/biosimilars manufacturing laboratory environment.
- Working knowledge of cGMP regulations, including 21 CFR 210/211/820.
- Strong background in small molecule and protein chemistry, with experience troubleshooting analytical results.
- Demonstrated success writing, revising, and complying with SOPs, policies, and QC methods.
- In-depth understanding and technical knowledge of analytical methods including UV absorbance, SDS-PAGE, HPLC, IEF, and ELISA in a QC laboratory environment.
- Familiarity with basic and some complex laboratory equipment and instrumentation.
- Strong written and verbal communication skills.
- Attention to detail and effective time management to complete assignments.
- Excellent computer skills in Microsoft Office applications.
- Ability to read, write, and understand English.
- Ability to work flexible hours as needed and work under pressure to meet deadlines.
Responsibilities
- Perform analytical testing supporting product in-process, release, and stability programs.
- Conduct, compile, and/or review out-of-specification laboratory investigations, deviations, and corrective and preventive action plans.
- Work with cross-functional teams to advance projects, maintain equipment, and author documents and reports.
- Perform other functions as required or assigned.
- Comply with company policies and standards.
Benefits
- Short-term incentive opportunity, such as a bonus or performance-based award.
- Long-term incentive award, such as restricted stock units.
- Health and insurance benefits.
- 401(k) matching contribution.
- Employee well-being programs.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
