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:

• 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:

• Foster a culture of collaboration, scientific excellence, and continuous improvement 

• Manage performance, career development, and talent growth within the team 

Required Qualifications 

• Ph.D. or M.S. in Chemical Engineering, Biochemical Engineering, Biotechnology, or a related discipline 

• 8+ years of experience in biopharmaceutical process development and commercialization, including viral vector manufacturing 

• Proven leadership in late-stage process development, process characterization, PPQ, and regulatory filings (BLA/MAA) 

• Deep understanding of lentiviral or viral vector manufacturing platforms, including transient transfection, purification, and formulation 

• Demonstrated success managing cross-functional technical teams and complex global programs 

• Excellent communication skills with experience interfacing with internal stakeholders and external partners 

Preferred Qualifications 

• Prior experience leading end-to-end lentivirus process development from development through commercialization 

• Expertise in regulatory submissions (IND, BLA, MAA) and Health Authority interactions 

• Familiarity with GMP manufacturing, validation principles, and lifecycle management of commercial products 

• Strong understanding of analytical method integration and control strategy development 

• Demonstrated ability to lead multi-site collaborations and global teams 

The annual base salary for this position ranges from $ 161,252.80 - $241,879.20. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, and experience. Also, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles).

Our Benefits:

Benefits offered include:

• A qualified retirement program [401(k) plan]

• Paid vacation, holidays, and paid leaves

• Health benefits including medical, prescription drug, dental, and vision coverage following the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment.

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