The Role:ElevateBio is looking for a dynamic individual to join and, contribute to building the manufacturing operations team at our BaseCamp facility. The incumbent will ultimately perform routine cGMP manufacture of multiple cell and gene therapy types/products at our state-of-the-art BaseCamp facility such as CAR-Ts, iPSCs, TILs, and mRNA. The individual should be a motivated self-starter eager to contribute to supporting a manufacturing organization unparalleled in its capabilities and expertise, have a willingness and aptitude for adoption of new technology, an ability to build relationships and work effectively in a cross-functional team, and commitment to the highest safety and quality standards.
Here's What You'll Do:- 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.
- Provide constructive input for the selection and set-up of equipment, process, and material flows, etc.
- Execute and maintain training materials and curricula that support continuous improvement in the cGMP manufacture of cell therapy products.
- 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.
- Commitment to the highest safety and quality standards in service of our colleagues and patients.
- Execute and review batch records, run reports, batch data, etc. for manufacturing and scale-up activities.
- Proactively identify opportunities for improvements in safety, quality, delivery and cost
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.
- 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.
- 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.
Work Schedule:- Must be available to overtime on weekdays, weekends and holidays as needed.
Physical Requirements:- Employee will frequently stand, walk, bend, stretch for extended periods
- Routinely carry up to 25 pounds and up to 50 pounds.
- Routinely push, pull, bend, kneel, twist, and climb step ladders while wearing PPE.
- Routine repetitive use of arms/wrist/hands.
- Ability to work nights, weekends, holidays as needed to support business needs.
The budgeted range for this position is $38/hour - $52/hour. This range is a good faith estimate of the expected hourly range for this position, based on a wide range of factors including qualifications, experience and training, operational and business needs and other considerations permitted by law.
