Biomanufacturing Associate II

The Role

ElevateBio is seeking a dynamic Biomanufacturing Associate II to join the manufacturing operations team at our BaseCamp facility. The successful candidate will be responsible for performing routine cGMP manufacture of various cell and gene therapy products, contributing to a manufacturing organization that is leading in capabilities and expertise.

Here’s What You’ll Do

• Perform routine right-first-time cGMP manufacturing of cell and gene therapy products including aseptic processing, cell isolation, selection, culturing, cryopreservation, upstream processing, downstream processing, aseptic fill finish, and final product visual inspection.
• Review and author SOPs and batch records, manage material ordering, and provide input for equipment, process, and material flow selection.
• Execute and maintain training materials for continuous improvement in cGMP manufacture of cell therapy products.
• Collaborate with Quality Assurance and Manufacturing Support and Technical Affairs to resolve issues like deviations, CAPAs, and change controls.
• Work effectively with cross-functional teams to ensure right-first-time manufacturing.
• Commit to the highest safety and quality standards.
• Execute and review batch records, run reports, and batch data for manufacturing and scale-up activities.
• Identify and implement 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 in cell and gene therapies.
• Experience with 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.
• Outstanding communication skills (verbal and written).
• Excellent computer and word processing skills including Microsoft Excel, PowerPoint, and Word.
• Proficiency in aseptic technique and/or processing.
• Ability to function in a dynamic environment and balance multiple priorities simultaneously.

Work Schedule

• Rotating 12-hour day shifts (0700-1900).
• Must be available to work overtime on weekdays, weekends, and holidays as needed.

Physical Requirements

• Frequent standing, walking, bending, stretching 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, and holidays as needed to support business needs.

Pay

The budgeted range for this position is $38/hour - $52/hour.

Benefits

ElevateBio is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to 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.