Director, Viral Vector Process Characterization and Commercialization

We are looking for an experienced leader to lead our viral vector late-stage process development and commercialization activities. The Director, Viral Vector Process Characterization and Commercialization, Process Engineering, will oversee and ensure rapid development and commercialization of robust, compliant and cost-effective viral vector manufacturing processes working with internal and external development and manufacturing teams. 

The successful candidate will direct a team of process engineers responsible for design, execution, and interpretation of process characterization studies across upstream, downstream, and vector fill operations. This role partners cross-functionally with Drug Product (Cell Therapy Process), Analytical, Quality, Regulatory, and Operations teams to ensure development, validation and maintenance of control strategy and regulatory strategy from late-stage development through commercialization. 

Key Responsibilities:

Strategic Leadership & Oversight:

• Lead the design, execution, and interpretation of process characterization and validation studies for viral vector manufacturing processes 

• Oversee PPQ and commercial readiness activities at internal and/or external sites (e.g., CDMO) 

• Provide end-to-end technical ownership starting from raw materials (cell banks, plasmids), upstream, downstream through vial fill operations. 

Regulatory & Documentation:

• Lead the preparation, review, and authoring of CMC documentation, including process descriptions, FMEAs, control strategies, validation protocols, CTD content, and regulatory agency responses 

• Contribute to BLA, MAA, and other global marketing applications, ensuring scientific and regulatory consistency across filings 

• Support post-approval changes, comparability studies, and lifecycle management submissions. 

Cross-Functional Collaboration:

• Partner with Analytical Sciences, Quality, Regulatory, and Manufacturing Operations to drive an integrated control strategy for process performance qualification and validation 

• Align with internal and external manufacturing networks to ensure successful technology transfer, execution of PPQ runs, and resolution of technical issues 

• Represent late-phase development in cross-functional governance, risk reviews, and strategic portfolio discussions 

People Management & Development:

• Lead, mentor and develop a high-performing team o