Principal Scientist (Vector) - MSAT

About the role

The Principal Scientist (Vector) – Manufacturing Sciences and Technology will be responsible for designing, leading, executing and overseeing internal and external studies and teams to support product and process optimization and automation, aseptic process validation and requalification campaigns, technology transfer activities, BLA supporting process and product characterization studies, BLA authoring, investigation into deviations and root cause analysis, change management and any activities required by the MS&T organization. This position bridges deep viral-vector knowledge with external manufacturing management and internal DS/DP manufacturing ensuring outsourced vector production (LVV) meets yield, quality, and regulatory requirements.

Responsibilities

The following reflects management’s definition of essential functions for this job but does not restrict the tasks that may be assigned. Management may assign or reassign duties and responsibilities to this job at any time due to reasonable accommodation or other reasons.

• 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.