Biomanaufacturing Associate III

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 (AAV) Lentivirus (LV) and mRNAs.  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. 

Here’s What You’ll Do:

• Routine right-first-time cGMP manufacturing of viral vectors and mRNA including but not limited to upstream, downstream, and aseptic fill finish and processing.
• 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 viral vectors and mRNA.
• 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 closely 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 w/4-8 years of experience in cGMP biotech manufacturing preferred.
• High school equivalency w/6-10 years of experience in cGMP biotech manufacturing.
• 4-8 years of experience in cGMP biotech manufacturing.
• 2-6 years of Cell Therapy/Viral Vector/mRNA manufacturing experience.
• 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.
• Willingness to cross-train in cell therapy manufacturing.

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.