Specialist, Quality Control Analytical, Cell Therapy; Sunday - Wednesday (4x 10 hour day shift)

Rockville, Maryland

About the role

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.

Responsibilities

• 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 relevant electronic systems and forms; author/review SOPs and test methods, ensure readiness for internal/external audits and regulatory inspections.
• 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.
• Complete method qualifications and maintain analyst proficiency; provide peer training on established procedures as qualified.
• Coordinate daily testing priorities, sample receipt, and material control with the team; communicate testing status and risks to ensure on-time lot release.

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 maintain a positive, solutions-oriented attitude to drive outcomes.
• Ability to work on-site in a lab-based role for the assigned shift.

Schedule

4 days per week, 10 hours per day shift, Sunday through Wednesday.

Pay

The annual base pay for this position ranges from $80,909.60 to $121,364.40. Positions offer eligibility for various incentives, including short-term incentive bonuses, equity-based awards for salaried roles, and commissions for sales roles.

Benefits

• Qualified retirement programs.
• Paid time off (vacation, holiday, and leaves).
• Health, dental, and vision coverage in accordance with the terms of the applicable plans.