Specialist, Quality Control Analytical, Cell Therapy ( Wed - Saturday)
About The Position
The Specialist, QC Analytical, performs routine and non-routine analytical testing to support cGMP lot release and stability of cell therapy products. The role executes approved methods, including flow cytometry, ELISA, PCR, automated cell counting, and other cell-based assays, while maintaining high quality, data integrity, and accurate documentation. The specialist also participates in laboratory investigations and collaborates with the QC team and cross-functional partners to meet testing timelines and ensure compliant operations. This is an on-site, lab-based role in Rockville, Maryland, working four 10-hour days per week, Wednesday through Saturday.
Requirements
- Bachelor’s degree in Biological Sciences, Chemistry, Biochemistry, or a related discipline.
- At least 3 years of experience with laboratory techniques relevant to cell therapy or biologics.
- Hands-on experience with analytical methods for cell therapy or biologics, including flow cytometry, ELISA, PCR, cell culture, cell count/viability, and functional cell-based assays.
- Familiarity with associated instrumentation and software.
- Ability to collaborate effectively across functions, adapt in an evolving environment, and maintain a positive, solutions-oriented attitude.
- Ability to work on-site in a laboratory for the assigned shift.
Responsibilities
- Execute QC testing for cell therapy products, including flow cytometry, ELISA, PCR, cell-based assays, and cell count/viability, using approved methods and SOPs and meeting cGMP, GDP, and ALCOA+ expectations.
- Operate, calibrate, maintain, and troubleshoot relevant instruments; document activities and promptly escalate issues.
- Maintain accurate, contemporaneous records in electronic systems and forms; author or review SOPs and test methods; support readiness for audits and regulatory inspections.
- Participate in laboratory investigations, including OOS/OOT events and deviations, by gathering data, conducting preliminary assessments, and documenting findings.
- Support implementation of CAPAs and change controls.
- Complete method qualifications and maintain analyst proficiency; provide peer training on established procedures when qualified.
- Coordinate daily testing priorities, sample receipt, and material control with the team.
- Communicate testing status and risks to help ensure on-time lot release.
Benefits
- Eligibility for short-term incentive bonuses.
- Equity-based awards for salaried roles.
- Qualified retirement programs.
- Paid time off, including vacation, holidays, and leaves.
- Health coverage.
- Dental coverage.
- Vision coverage.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
