Scientist II, Process Development

Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life‑threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T‑cell, T‑cell receptor (TCR‑T), and natural killer (NK) cell‑based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting‑edge therapeutics for patients worldwide.

The Scientist, Process Development (PD) will be responsible for developing, establishing, and optimizing processes to be used in the manufacturing of Legend’s gene and cellular therapy pipeline and first‑in‑human/new IND products. The candidate will have demonstrated technical experience working in multidisciplinary research and process development labs to define robust manufacturing processes and/or associated analytical systems, supporting the development of scalable, cGMP‑compliant processes and documentation for the manufacturing of novel allogeneic cellular and gene therapeutic products.

This position requires prior experience with mammalian cell culture, process development for cellular and gene therapies and excellent technical, organizational, and interpersonal skills.

• Support the design of complex process development studies under the leadership of senior level technical staff.
• Work within a team to deliver phase‑appropriate process development components of projects with scientific excellence and patient‑focus according to Technical Development and Company’s strategic objectives.
• Work according to appropriate standards for quality, ethics, health, safety, environmental protection and information security; participate activities that are aligned with organizational workflow and procedures.
• Execute the development studies in the lab, document the procedure, and interpret process development experiment results.
• Execute the bespoke manufacturing process in the GMP suite, document the procedure on M  in a GMP compliant environment.
• Author technical protocols, technical reports, SOPs and MBRs for the manufacturing process.
• Maintain accurate and updated lab notebooks and manufacturing records.
• Manage equipment and records for maintenance, calibration, cleaning and operation, and lead the effort to maintain laboratory inventories.
• Provide technical support and expertise as SME for manufacturing root cause investigations for Deviations and CAPA.
• Use statistical tools to analyze and organize process development and manufacturing data with scientific integrity, and in clear and concise manner.
• Author technical documents to support regulatory filings; collaborate with EDD, Analytical Development, Material Science and other cross‑functional teams to support the establishment of development strategy for new product and supply materials to support pre‑clinical studies and associated activities; use professional concepts in accordance with company objectives to solve complex problems in creative and effective ways.
• Evening and weekend work as deemed necessary according to project timeline.

• Advanced degree (BS, MS, PhD) in immunology, cell biology, biomedical engineering, or equivalent. Technical training / certification is desirable.
• 3‑5 years of experience in process development of gene or gene‑modified products in a biotech, academic, or pharmaceutical setting.
• Experience in biotechnology bioprocessing, gene and cell therapy process development and/or GMP manufacturing.
• Experience working with viral vectors and gene editing is a plus.
• Authoring SOPs/procedures for established and new procedures.
• Ability to transfer processes to internal or external manufacturing sites.
• Ability to work independently and successfully prioritize and manage multiple tasks simultaneously, integrate cross‑functional issues and balance competing priorities effectively.
• Ability to manage shifting priorities to meet critical deadlines in a fast‑paced and dynamic, growing environment.
• Ability to work collaboratively with…