Specialist, Quality Control Analytical, Cell Therapy

Regulatory Toolkit; Rockville (MD); On-site; USD 81,000 - 121,000; Full time

Benefits offered by this job

401(k) plan

Paid time off

Health, dental, and vision coverage

Job summary

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.

Qualifications

• 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.

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 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.

Skills

Flow cytometry

ELISA

PCR

Cell culture

Cell counting

Viability assessment

Instrumentation software

Education

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

Tools

Instrumentation

Laboratory software

Job description

Job Description

Role Overview - Rockville, Maryland

The Specialist,QCAnalytical, performs routine and non-routine analytical testing to supportcGMP lotrelease 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,maintainsaccuratedocumentation, 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 positionisfora4days per week, 10 hoursper day shift,Wednesday - Saturday

Role Responsibilities

Analytical testing:Execute QC testing for cell therapy products (flow cytometry, ELISA, PCR,cell basedassays, 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 elevate issues promptly.

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

Quality systems:Participatein 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 andmaintainanalystproficiency; 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.

MinimumRequirements

• Bachelor’s degree in Biological Sciences, Chemistry, Biochemistry, or related discipline.
• Minimum of 3years’ experiencewithlaboratory 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, andmaintainsa positive,solutions‑orientedattitude to drive outcomes.
• Ability to work on‑site in a lab-based rolefor the assigned shift.

The annual base pay (or hourly rate of compensation) for this position ranges from $80,909.60 - $121,364.40.Our positions offer eligibility for various incentives—an opportunity to receive short-term incentive bonuses, equity‑based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.

Date Posted

18-Oct-2026

Closing Date

12-Nov-2026

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.