Director, Viral Vector Process Characterization and Commercialization

We are looking for an experienced leader to lead our v iral v ector l ate- s tage p rocess d evelopment 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 executi on and interpretation of process characterization studies across upstream downstream and vector fill operations. This role partners cross-functionally with Drug Product ( Cell T herapy P rocess ) 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 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

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 $ 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.

#celltherapy #LI-Onsite

Date Posted

06-Nov-2025

Closing Date

12-Nov-2025

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and 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.

Required Experience :

Director

Key Skills

CNC,Computer Software,Equity Research,Investment,ITI

Employment Type : Full-Time

Experience : years

Vacancy : 1

Monthly Salary Salary : 161252 - 241879