Scientist I, Process Development

Responsibilities

• Support the design of complex process development studies focusing on vector bioprocessing and cell processing workflows
• Execute bioprocess development studies in the lab including bioreactor runs, upstream engineering, and downstream processing
• Execute bespoke manufacturing processes in the GMP suite and document procedures on Master Batch Records (MBRs)
• Author technical protocols, technical reports, SOPs, and MBRs for manufacturing processes
• Manage equipment maintenance, calibration, cleaning, and laboratory inventories
• Provide technical support and engineering expertise for manufacturing root cause investigations (Deviations and CAPA)
• Use engineering and statistical tools to analyze and organize process development and manufacturing data
• Collaborate with cross-functional teams including Analytical Development and Material Science

Requirements

• Advanced degree (BS, MS, PhD) in process engineering, immunology, cell biology, or equivalent
• BS with 3-5 years, MS with 2-3 years, or PhD with 1-2 years of experience in process development of gene or gene-modified products
• Core engineering background in bioprocessing of biologics, vaccines, and viral vectors
• Hands-on experience with bioreactors (upstream) and downstream processing (filtration, chromatography, TFF)
• Experience with mammalian cell culture, primary cell processing, and cellular expansion
• Proven experience authoring SOPs and procedures
• Proficiency in using statistical tools like JMP or GraphPad and visualization tools like PowerBI

Preferred Qualifications

• Proficiency in cGMP and FDA guidelines
• Technical training or certification in relevant fields

About the Company

Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, they develop advanced cell therapies including autologous and allogenic CAR-T, TCR-T, and NK cell-based immunotherapies.