Manufacturing Associate II
On-site · Houston, Texas, United States
Job Summary
Manufacturing Associate II to support the CMC-GMP Manufacturing team. Responsible for performing complex, time-sensitive technical cell manipulation and testing procedures on irreplaceable cellular products during clinical manufacturing. Role requires adherence to cGMP, regulatory standards, and accurate documentation; includes cell growth/manipulation (enrichment, culture, cryopreservation, thaw/wash), aseptic handling, deviation reporting, and investigation support. Schedule is 2:30 PM–11:00 PM, Monday–Friday, on-site in Stafford/Houston area, TX.
Required Qualifications
- Two years of cell therapy manufacturing experience
- Associate degree in biology, Biochemistry, Biotechnology, Biomanufacturing or related field OR Biomanufacturing Technology AS/Level 2 Certificate OR equivalent
- Knowledge of current cGMP
- Experience performing cell growth and manipulation procedures (cell enrichment, culture, cryopreservation, thaw/wash)
- Ability to adhere to SOPs and regulatory requirements (FDA GLP, cGMP, cGDocP, FACT, CAP, CLIA)
- Aseptic handling of reagents and products; specialized gowning requirements
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