Elevatebio
Biomanufacturing Associate II
Waltham, Massachusetts, United States · Mid
Sponsorship not specifiedDetected 36 days ago
ExcelGMPCRISPRCell CultureCommunication
About the role
- Provide constructive input for the selection and set-up of equipment, process, and material flows, etc.
- Work with Quality Assurance and MSAT to proactively resolve issues such as deviations, CAPAs, Change Controls.
- Work effectively with cross functional teams comprised of process development, facilities & engineering, MSAT, quality control, and quality assurance to ensure right-first-time manufacturing.
Responsibilities
- Perform routine right-first-time cGMP manufacturing of cell and gene therapy products including but not limited to aseptic processing, cell isolation, selection, culturing, cryopreservation, upstream processing, downstream processing, aseptic fill finish and final product visual inspection.
- Perform manufacturing activities including but not limited to reviewing / authoring SOPs and batch records, as well as material ordering / management.
- Execute and maintain training materials and curricula that support continuous improvement in the cGMP manufacture of cell therapy products.
Requirements
- Bachelor's degree in biological science(s) field or related engineering with 2-4 years of experience in cGMP biotech manufacturing, preferably cell and gene therapies.
Nice to have
- Understanding of primary cell culture and experience with equipment such as BSC, Microscope, LOVO, CliniMACS, Incubators, Centrifuges, CRF, and G-Rex systems is preferred.
- Outstanding communication skills (verbal and written).
- Excellent computer and word processing skills including Microsoft Excel, PowerPoint, and Word
- Demonstrate proficiency in aseptic technique and/or processing.
- Ability to function in dynamic environment and balance multiple priorities simultaneously.
- Experience with some of the following is preferred: cGMP manufacture and/or process development for CAR T, TCR, TIL, cell and gene therapies, and mRNA.
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