Principal Scientist (Vector) - MSAT

Duties and Responsibilities

• Provide technical leadership and support for technology transfer, process optimization, and technology evaluation to support development and commercialization of new and existing products.
• Develop, qualify, and execute phase-appropriate studies for the characterization and development of multiple pipeline products
• Leads process lifecycle management for both commercial and approaching BLA CGT programs.
• Collaborate with Quality Assurance, Regulatory Affairs, Analytical Sciences, Supply Chain, and Facilities to align strategic priorities and project timelines.
• Utilize statistical process control tools to monitor manufacturing metrics, prepare continued process verification reports, and ensure inspection readiness.
• Mentor junior scientist and foster a culture of collaboration and technical excellence. May manage a small to mid-sized team
• Represent Manufacturing Sciences and Technology team in cross-functional technical meetings.
• Aseptic process lead and oversight: coordinate across multi disciplines, including QA, QC Micro, Manufacturing, MS&T, Regulatory, Engineering, for aseptic process validation activities, ensuring timely execution and audit readiness.
• Provide aseptic process technical expertise and guidance for risk assessments, validation documentation.
• Act as SME for sterility assurance topics, supporting investigation and leading continuous improvement to improve the aseptic simulation program.
• Facilitate product transfers by aligning aseptic validation approaches.
• Review and approve change controls, ensuring validation impact assessments, and appropriate testing to maintain validated states.
• Support the execution of improvement projects, liaising with all the relevant parties to ensure accurate execution.
• Support with any internal or external audit.
• Lentiviral process subject matter expert (SME) for deviations, root cause investigations, root-cause analyses, and CAPAs related to LVV vector production.
• Manage lentiviral vector manufacturing process lifecycle governance.
• Evaluate lentiviral manufacturing process changes, shipping validation parameters, deviations, and out-of-trend events.
• Interface with contract development and manufacturing organizations for external lentivirus production.
• Author, review, and defend lentiviral vector process

Qualifications

Required:

• B.S., M.S. or Ph.D. in cell and/or molecular biology, engineering, or relevant discipline with a minimum of 4 years (PhD), 8 years (M.S.) or 10 years (B.S.) of industry experience.
• Proven understanding of aseptic techniques, FDA/EU regulatory requirements and guidelines for validation.
• Knowledge and experience in developing manufacturing processes with understanding of regulatory constraints relating to cGMP, Annex 1, and ATMP guidance.
• Experience in working in cross-functional environments, and with internal/external partners to perform process transfer for cGMP production.
• Proficiency in project management and resource planning
• Strong understanding of adeno-associated virus (AAV), or lentivirus vector (LVV) production is required

Desirable:

• Experience managing or providing oversight of CROs/CMOs
• Experience with regulatory submissions (IND, BLA, MAA) for advanced therapies.
• Proficiency in Quality by Design (QbD) principles and statistical data analysis.