Cell Therapy QC Analyst - Analytical Testing (4x10h)

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

Benefits offered by this job

Incentives program

Retirement plan

Paid time off

Health, dental, and vision coverage

Job summary

Regulatory Jobs is seeking a QC Analytical Specialist in Rockville, MD to perform routine and non-routine analytical testing supporting cGMP lot release and stability of cell therapy products. You will execute approved methods (flow cytometry, ELISA, PCR, cell-based assays) with data integrity and documentation, collaborating with cross-functional teams to meet testing timelines.

This role requires a Bachelor’s degree and at least 3 years of hands-on lab experience, with the ability to work

Qualifications

• Bachelor's degree required in Biological Sciences, Chemistry, Biochemistry, or related field.
• 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 (flow cytometry, ELISA, PCR, cell culture, cell count/viability, functional assays); familiar with instrumentation/software.
• Demonstrate cross-functional collaboration, flexibility in a evolving environment, and a positive, solutions-oriented attitude.

Responsibilities

• Analytical testing: perform QC testing for cell therapy products per approved methods and SOPs, meeting cGMP, GDP, and ALCOA+ expectations.
• Instrument operation and maintenance: operate, calibrate, and maintain instruments; document activities and escalate issues promptly.
• Documentation and compliance: maintain accurate records and contribute to SOP/test method development; support audits.
• Quality systems: participate in investigations (OOS/OOT, deviations) and support CAPAs and change controls.
• Training and knowledge sharing: complete method qualifications and train peers as needed; ensure analyst proficiency.

Skills

Flow cytometry

ELISA

PCR

Cell culture

Cell counting/viability

Cross-functional collaboration

Education

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

Tools

Flow cytometer

ELISA reader

PCR instruments

Job description

Regulatory Jobs is seeking a QC Analytical Specialist in Rockville, MD to perform routine and non-routine analytical testing supporting cGMP lot release and stability of cell therapy products. You will execute approved methods (flow cytometry, ELISA, PCR, cell-based assays) with data integrity and documentation, collaborating with cross-functional teams to meet testing timelines.

This role requires a Bachelor’s degree and at least 3 years of hands-on lab experience, with the ability to work