Director, Viral Vector Process Characterization and Commercialization

We are looking for an experienced leader to lead ourviralvectorlate-stageprocessdevelopment andcommercialization activities.TheDirector Viral Vector Process Characterizationand Commercialization Process Engineeringwill oversee and ensure rapiddevelopment andcommercialization of robustcompliantand cost-effectiveviral vectormanufacturing processes working withinternal and externaldevelopment andmanufacturingteams.

The successful candidate will direct a team ofprocess engineersresponsible for design execution andinterpretation ofprocess characterization studies across upstream downstream andvectorfill operations. This role partners cross-functionally withDrug Product (CellTherapyProcess) Analytical Quality Regulatory and Operations teams to ensuredevelopment validation and maintenance ofcontrol strategy and regulatorystrategyfrom late-stagedevelopment through commercialization.

Key Responsibilities:

Strategic Leadership & Oversight:

• Oversee PPQ and commercial readiness activities atinternal and/orexternalsites (e.g. CDMO)

• Provide end-to-end technical ownershipstartingfromraw materials (cell banks plasmids)upstreamdownstreamthroughvialfill operations.

Regulatory & Documentation:

• Leadthe preparation review and authoring of CMC documentation including process descriptions FMEAs control strategies validation protocolsCTD content and regulatoryagencyresponses

• 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 integratedcontrolstrategy 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

• Expertisein 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 $ 161252.80 - $241879.20. 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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