Manufacturing Associate I - Cell Therapy
Overview
You will own manufacturing operations for cell therapy products that treat cancer patients. As Manufacturing Associate I, you will execute cell growth and manipulation steps including cell enrichment, cryopreservation, and thawing, ensuring product integrity through final patient infusion. You will work in a GMP cleanroom (Grade A/B/C/D) with a team of scientists and technicians. This 8-month contract offers a chance to master FDA regulations and ALCOA++ data integrity in a cutting-edge biomanufacturing facility.
What You'll Do10
- 1Serve as operator or verifier for cell enrichment, culture, cryopreservation, thawing, and washing procedures.
- 2Execute manufacturing activities in compliance with FDA GLP, GMP, GTP, and FACT, CAP, and CLIA standards.
- 3Adhere to ALCOA++ and cGDocP requirements while maintaining accurate batch records and documentation.
- 4Ensure aseptic handling of reagents and cellular products to maintain sterility from processing through final patient infusion.
- 5Follow strict cleanroom gowning and environmental procedures in Grade A/B/C/D environments.
- 6Identify and document deviations, notify leadership and Quality, and support root cause investigations and CAPAs.
- 7Perform calculations for cell viability, dilutions, and concentrations.
- 8Maintain GMP cleanliness including autoclaving, waste handling, and facility organization.
- 9Support validation activities including IQ/OQ/PQ and provide input on change controls, SOPs, and investigations.
- 10Perform routine equipment maintenance and troubleshooting.
Requirements9
- 1Associate degree or enrollment in Biology, Biotechnology, or Biomanufacturing.
- 20–2 years of experience in a regulated manufacturing environment.
- 3Knowledge of FDA regulations including GLP, GMP, and GTP.
- 4Experience with aseptic techniques and cleanroom protocols.
- 5Ability to follow SOPs and maintain accurate documentation.
- 6Basic problem-solving and critical thinking skills.
- 7High initiative and motivation to exceed expectations.
- 8Strong organizational and prioritization skills.
- 9Coachability and responsiveness to feedback.
Salary Insight
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