Scientist I, Process Development

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.
• Execute bioprocess development studies in the lab (including bioreactor runs, upstream engineering, and downstream processing).
• Document the procedure and interpret process development experiment results.
• Execute the bespoke manufacturing process in the GMP suite and document the procedure on Master Batch Records (MBRs).
• 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.
• Provide technical support and engineering expertise as a Subject Matter Expert (SME) for manufacturing root cause investigations for Deviations and CAPA.
• 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.
• Solve complex bioprocessing problems in creative and effective ways.
• Work within a fast-paced and dynamic environment, managing shifting priorities to meet critical deadlines.

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.