Cell Therapy QC Analytical Specialist – On-site

Regulatory Jobs; Rockville (MD); Vor Ort; USD 81.000 - 121.000; Vollzeit

Benefits dieser Stelle

401(k) plan

Paid time off

Health, dental, and vision coverage

Zusammenfassung

Regulatory Jobs is seeking a Specialist, QCAnalytical in Rockville, MD to perform routine and non-routine analytical testing for cell therapy products. Duties include executing flow cytometry, ELISA, PCR, and cell-based assays while maintaining cGMP, GDP, and ALCOA+ standards.

The role requires on-site work 4 days a week, 10 hours per day (Wednesday–Saturday), with responsibilities spanning instrument maintenance, documentation, and participation in investigations.

Qualifikationen

• Bachelor’s degree in Biological Sciences, Chemistry, Biochemistry, or related discipline required.
• Minimum of 3 years’ 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 related instrumentation and software.
• Demonstrated cross-functional collaboration and flexibility in a dynamic environment; positive, solutions‑oriented attitude.
• Ability to work on-site in a lab-based role for the assigned shift.

Aufgaben

• Execute QC testing for cell therapy products (flow cytometry, ELISA, PCR, cell-based assays, cell count/viability) per approved methods and SOPs, meeting cGMP, GDP, and ALCOA+ expectations.
• Operate, calibrate, and perform routine maintenance and troubleshooting on relevant instruments; document activities and escalate issues promptly.
• Maintain accurate, contemporaneous records in electronic systems; author/review SOPs and test methods; ensure readiness for audits and inspections.
• Participate in laboratory investigations (e.g., OOS/OOT, deviations), gather data, and document findings; support CAPAs and change controls.
• Complete method qualifications and maintain analyst proficiency; provide peer training on established procedures.
• Coordinate daily testing priorities, sample receipt, and material control; communicate testing status and risks for on-time lot release.

Kenntnisse

Flow cytometry

ELISA

PCR

Cell culture

Cell counting

Viability assessment

Instrumentation software

Ausbildung

Bachelor’s degree in Biological Sciences, Chemistry, Biochemistry, or related discipline

Tools

Instrumentation

Laboratory software

Jobbeschreibung

Regulatory Jobs is seeking a Specialist, QCAnalytical in Rockville, MD to perform routine and non-routine analytical testing for cell therapy products. Duties include executing flow cytometry, ELISA, PCR, and cell-based assays while maintaining cGMP, GDP, and ALCOA+ standards.

The role requires on-site work 4 days a week, 10 hours per day (Wednesday–Saturday), with responsibilities spanning instrument maintenance, documentation, and participation in investigations.