Ruben Lopez
CMC-GMP Manufacturing Associate II at Immatics
- Role
- Cmc-gmp Manufacturing Associate Ii at Immatics
- Location
- Houston, TX, US
- LinkedIn followers
- 500 followers
Experience
Cmc-gmp Manufacturing Associate Ii
Feb 2025 — Present · Houston, TX, US
The primary purpose of this position is to perform complex, highly specialized and time sensitive technical cell manipulation and testing procedures on irreplaceable cellular products during clinical manufacturing.Essential Functions:• Knowledge of current cGMP.• Fulfill the operator and verifier roles in performing cell growth and manipulation procedures such as cell enrichment, cell culture, cellular product cryopreservation, cell product thaw/wash.• Accurately perform procedures in compliance with FDA’s Good Laboratory Practices, Good Manufacturing Practices, Good Tissue practices, as well as standards set by other accreditation agencies including but not limited to FACT, CAP, and CLIA. • Adhere to ALCOAC++ and cGDocP requirements while accurately performing procedures and maintaining documentation in compliance with SOPs.• Document deviations and events and assist in investigation of root cause, and any required corrective actions.• Responsible for aseptic handling of reagents and products to ensure the integrity and sterility of cellular products until final infusion to the patient. Must adhere to special cleaning and gowning requirements for the facility requiring specialized gowning such as masks, sterile jumpsuits, hair and shoe covers.• Ability to work productively and to participate in a highly creative and fast-paced environment.• Independently perform calculations to determine cell viability, dilutions, and cell concentrations. • Completes all appropriate logs and trackers.• Maintains knowledge regarding donor evaluation, screening and testing, labeling and product acceptability and release criteria.• Conducts activities to support study plans, and IQ/OQ/PQs.• Provide input or feedback regarding change controls, WI, SOPs, study plans, reports, deviations, OOS/OOE, and CAPA’s as directed.• Performs routine equipment maintenance and troubleshooting.• Prepares and presents manufacturing summaries.
Education
University of Houston
Minor
2018 — 2022
University of Houston
Bachelor's degree
2018 — 2022
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