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 Engineering,will oversee and ensure rapiddevelopment andcommercialization of robust,compliantand 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:
Lead the design, execution, and interpretation of process characterization and validation studies for viral vector manufacturing processes
Oversee PPQ and commercial readiness activities atinternal and/orexternalsites (e.g., CDMO)
Provide end-to-end technical ownershipstartingfromraw materials (cell banks, plasmids),upstream,downstreamthroughvialfill operations.
Regulatory & Documentation:
Leadthe preparation, review, and authoring of CMC documentation, including process descriptions, FMEAs, control strategies, validation protocols,CTD 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:
Lead,mentorand develop a high-performingteam of engineers.
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 $ 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.
#celltherapy #LI-Onsite
Date Posted
06-Nov-2025Closing Date
12-Nov-2025Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.
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