Supervisor, Manufacturing

ElevateBio is a technology-driven company powering the industry forward by helping partners realize the potential of their therapies from design to commercialization. We have integrated a differentiated set of technologies, end-to-end services, and industry-leading manufacturing expertise to develop advanced therapies faster and more efficiently.

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:

• Lead right-first-time cGMP manufacturing of cell and gene therapy products including but not limited to aseptic processing, cell isolation, selection, culturing, expansion, harvest, cryopreservation and final product visual inspection.
• Lead manufacturing activities including but not limited to authoring SOPs, batch records, reports, risk assessments, material ordering/management.
• 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 development, facilities & engineering, MSAT, quality control and quality assurance to ensure right-first-time technology transfer.
• Work with Quality Assurance and MSAT 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 areas such as safety, quality, delivery and cost.
• Be integral in providing hands-on technical, organizational, and leadership expertise to the manufacturing department including but not limited to equipment selection, SOPs, batch records, reports, risk assessments, material ordering/management.
• Ensure the safety of assigned areas and work practices in accordance with EHS program. Ensure JHA (Job Hazard Analysis) are reviewed regularly, and pre-job briefs are in place prior to execution.
• Provide daily management oversight for the team and ensure process are executed with cGMP.
• Recruit and develop staff, maintain, and report department metrics to drive operational improvement.
• Balance and prioritize daily production demands to ensure right first-time execution.

Requirements:

• Bachelor's degree in biological science(s) field or related engineering with 4-6 years of experience in cGMP biotech manufacturing, preferably cell and gene therapies.
• 2+ years of experience in people leading and/or project leadership.
• Experience with some or all of the following: cGMP manufacture and/or process development for CART, TCR, TIL, cellular therapies, and mRNA.
• Advanced understanding of primary cell culture and experience with equipment including but not limited to BSC, Microscope, LOVO, CliniMACS, Incubators, Centrifuges, CRF, and G-Rex systems.
• 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:

• Rotating 12-hour day shifts (0700-1900).
• 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.
• Ability to don job-specific PPE.

The budgeted range for this position is $50/hour - $69/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.

ElevateBio is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. ElevateBio will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.