The RoleElevateBio is looking for a dynamic individual to join and, contribute to building the manufacturing operations team at our Manufacturing site. The incumbent will ultimately perform routine cGMP manufacture of multiple cell and gene therapy types/products at our state-of-the-art facility such as CAR-Ts, iPSCs, Adeno-Associated Virus (AVV) and Lentivirus (LV). The individual should be a motivated self-starter eager to contribute to building a manufacturing operation 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 and lead 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/operations start-up activities including but not limited to authoring SOPs, batch records, reports, risk assessments, material ordering/management.
- Provide training to team on set-up and use of equipment, process and material flows, as assigned.
- Ensure clean rooms are maintained in an organized and ready state.
- Provide constructive input on teams for the selection and set-up of equipment, process and material flows, etc.
- Create and maintain training materials and curricula that support continuous improvement in the cGMP manufacture of cell therapy products.
- Work effectively with cross functional teams comprised of process sciences, development, facilities & engineering, tech ops, quality control, quality assurance, to ensure right-first-time technology transfer.
- Work closing with Quality Assurance and Process Sciences to proactively resolve issues such as deviations, CAPAs, Change Controls.
- Commitment to the highest safety and quality standards in service of our colleagues and patients.
- Generate and manage batch records, run reports, batch data, etc. for manufacturing and scale-up activities.
- Proactively identify opportunities for improvements in process, safety, quality, and cost
Requirements- Bachelor's degree and at least 2 years of related experience OR Master's degree with up to 1 year of related experience.
- Experience with some of the following is preferred: cGMP manufacture and/or process development for CAR T, TCR, NK, cellular therapies, AAV, LV, RV.
- Understanding of primary cell culture and experience with equipment such as CliniMACS Plus, CliniMACS Prodigy, LOVO, bioreactors (single-use and fixed-bed), chromatography skids, TFF (hollow-fiber and flat-sheet) and WAVE bioreactors such as Xuri, G-Rex system 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.
Physical and Environment Requirements:- Ability to stand, walk, bend and stretch for extended period of time
- Ability to lift 15-20 lbs
- Ability to push, pull, bend, kneel, twist and climb step ladders while wearing PPE.
- Ability to perform routine repetitive motions with use of arms, wrists and hands
- Ability to work nights, weekends, and 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.
