Scientist I, Process Development

Legend Biotech is seeking a Scientist I, Process Development as part of the Technical Development team based in Somerset, NJ.

Role Overview

The Scientist I, Process Development (PD) will be responsible for developing, establishing, and optimizing scalable manufacturing processes for 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. 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

Key Responsibilities

• Under the leadership of senior-level technical staff, support the design of complex process development studies focusing on both vector bioprocessing and cell processing workflows.
• Ability to 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 in activities aligned with organizational workflow and procedures.
• Ability to execute bioprocess development studies in the lab (including bioreactor runs, upstream engineering, and downstream processing), document the procedure, and interpret process development experiment results.
• Ability to execute the bespoke manufacturing process in the GMP suite, and document the procedure on Master Batch Records (MBRs) in a GMP-compliant environment.
• Author technical protocols, technical reports, SOPs, and MBRs for upstream, downstream, and cell therapy manufacturing processes.
• Ability to maintain accurate and updated lab notebooks and manufacturing records.
• Work within the team to manage equipment (such as bioreactors and purification systems) and records for maintenance, calibration, cleaning, and operation, and lead the effort to maintain laboratory inventories.
• Provide technical support and engineering expertise as a Subject Matter Expert (SME) for manufacturing root cause investigations for Deviations and CAPA.
• Ability to use engineering and statistical tools to analyze and organize process development and manufacturing data with scientific integrity, and in a clear and concise manner.
• Ability to work collaboratively with the EDD, Analytical Development, Material Science, and other cross-functional teams to support the establishment of development strategies for new biological/cell products and supply materials to support pre-clinical studies and associated activities.
• Ability to use professional concepts in accordance with company objectives to solve complex bioprocessing problems in creative and effective ways.
• Evening and weekend work as deemed necessary according to project timeline and culture schedules.

Requirements

• Advanced degree (BS, MS, PhD) in process engineering, immunology, cell biology, or equivalent. Technical training / certification is desirable.
• 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.
• Core engineering background in bioprocessing of biologics, vaccines, and viral vectors (including working with viral vectors and cell therapy).
• 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.
• Proficiency in cGMP and FDA guidelines is preferred.
• 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.

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