Specialist, Quality Control Analytical, Cell Therapy (Sun - Wed)
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—with a focus on quality and data integrity, maintains accurate documentation, and participates in laboratory investigations. The QC Specialist collaborates within the QC team and with cross-functional partners to meet testing timelines and ensure compliant operations. This is an on-site, lab-based position in Rockville, Maryland, working four days per week for 10 hours per day, Sunday through Wednesday.
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.
- Effective cross-functional collaboration skills, flexibility in an evolving environment, and a positive, solutions-oriented attitude.
- Ability to work on-site in a lab-based role for the assigned shift.
Responsibilities
- Execute QC testing for cell therapy products using flow cytometry, ELISA, PCR, cell-based assays, and cell count/viability methods in accordance with approved methods and SOPs and cGMP, GDP, and ALCOA+ expectations.
- Operate, calibrate, maintain, and troubleshoot relevant instruments; document activities and promptly escalate issues.
- Maintain accurate, contemporaneous records in relevant electronic systems and forms.
- Author and review SOPs and test methods, and support readiness for internal and external audits and regulatory inspections.
- Participate in laboratory investigations, including OOS/OOT events and deviations, by gathering data, performing 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 support 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, dental, and vision coverage in accordance with applicable plan terms.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
