Specialist, Quality Control Analytical, Cell Therapy (Sun - Wed)

Job Description

Role Overview - Rockville, Maryland

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 (e.g., flow cytometry, ELISA, PCR, automated cell counting, and other cell-based assays) with high 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 position is for a 4 days per week, 10 hours per day shift, Sunday through Wednesday.

Role Responsibilities

Analytical testing: 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.

Instrument operation and maintenance: Operate, calibrate, and perform routine maintenance and troubleshooting on relevant instruments; document activities and escalate issues promptly.

Documentation and compliance: Maintain accurate, contemporaneous records in relevant electronic systems and forms; author/review SOPs and test methods, ensure readiness for internal/external audits and regulatory inspections.

Quality systems : Participate in laboratory investigations (e.g., OOS/OOT, deviations) by gathering data, performing preliminary assessments, and documenting findings; support implementation of CAPAs and change controls.

Training and knowledge sharing : Complete method qualifications and maintain analyst proficiency; provide peer training on established procedures as qualified.

Planning and teamwork: Coordinate daily testing priorities, sample receipt, and material control with the team; communicate testing status and risks to ensure on-time lot release.

Minimum Requirements

• Bachelor’s degree in Biological Sciences, Chemistry, Biochemistry, or related discipline. • 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 associated instrumentation and software. • Demonstrate effective cross-functional collaboration, embrace flexibility in a constantly evolving environment, and maintains a positive, solutions‑oriented attitude to drive outcomes. • Ability to work on-site in a lab-based role for the assigned shift.