Biomanufacturing Associate II (Contract)

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, 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 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 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 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 in biological science(s) field or related engineering with:
  • For BMA II’s 1-3 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, 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.
• Work Schedule:
  • 12-hour rotating shifts, 7am-7pm
  • 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.