Scientist I, Process Development
Somerset, New Jersey, United States On-site
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About the role
Legend Biotech is seeking a Scientist I, Process Development as part of the Technical Development team based in Somerset, NJ. 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. This role supports the development of scalable, cGMP-compliant processes and documentation for novel allogeneic cellular, gene therapeutic, and biological products. This position requires prior experience with mammalian cell culture (cell line and primary cell), process development for cellular/gene therapies, and excellent technical, organizational, and interpersonal skills
What you'll bring
- Advanced degree (BS, MS, PhD) in process engineering, immunology, cell biology, or equivalent.
- BS with 3-5 years, MS with 2-3 years and PhD with 1-2 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.
- Hands-on experience working with bioreactors (upstream processing, scale down and scale up model) and downstream processing (e.g., filtration, chromatography, TFF) for lentivirus/AAV vectors, viral products, or biological entities.
- Experience handling the cell processing side for cell therapies, including mammalian cell culture, primary cell processing, and cellular expansion.
- Proven experience authoring SOPs/procedures for established and new engineering unit operations.
- Ability to transfer upstream and downstream bioprocesses to internal or external manufacturing sites.
- Ability to manage shifting priorities to meet critical deadlines in a fast-paced and dynamic, growing environment.
- Ability to work collaboratively with cross-functional engineering, manufacturing, and analytical teams.
- Detail-oriented with expertise in engineering problem solving and solid decision-making abilities.
- Excellent teamwork, emotional intelligence, and communication skills.
- Experience using statistical tools to analyze engineering data (JMP, GraphPad, etc.) and using visualization tools (PowerBI) to trend development and manufacturing data.