Scientist I, Process Development

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.

Key Responsibilities

• Support the design of complex process development studies focusing on both vector bioprocessing and cell processing workflows.
• 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.
• Execute bioprocess development studies in the lab (including bioreactor runs, upstream engineering, and downstream processing), document the procedure, and interpret process development experiment results.
• Author technical protocols, technical reports, SOPs, and MBRs for upstream, downstream, and cell therapy manufacturing processes.
• Maintain accurate and updated lab notebooks and manufacturing records.
• 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.
• Use engineering and statistical tools to analyze and organize process development and manufacturing data with scientific integrity, and in a clear and concise manner.
• Collaborate 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.
• 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.
• 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.