Technical Product Lead
The CMSC Technical Product Lead (Director) will provide cross-functional leadership across Commercial Manufacturing and Supply Chain (CMSC) for technical activities supporting product lifecycle. This role will be accountable for technical stewardship to meet strategic objectives by prioritizing key projects and investments encompassing process and method changes, sourcing and capacity, product lifecycle registrations, robustness/quality and productivity projects. The Director will ensure global alignment across CMSC functional teams, Quality and business stakeholders to meet Commercial Manufacturing & Supply Chain goals and targets.
- Collaborate with Strategic Product Leader to create an integrated exa-cel technical strategy, inclusive of the manufacturing process and analytical methods, that directs CMC lifecycle scope with consideration of product quality, patient supply, cost and all stakeholder wants and needs.
- Collaborate across functions to create and drive execution of the technical product roadmap (“technical agenda”), which details the projects and process improvements required to achieve strategic goals.
- Manage quarterly technical program reviews, inclusive of data trending, progress of technical roadmap and continued suitability of the technical strategy
- Assess all proposed CMC changes potentially impacting established or planned conditions, inclusive of those derived from manufacturing, testing, supply chain, commercial, health authority or industry; identify and communicate risks of potential changes; revise technical strategy and technical agenda as required
- Review and approve post-approval CMC regulatory content
- Serve as technical lead on strategic technical initiatives
- Support the establishment of network strategies for drug product manufacturing, critical components and testing
- Collaborate with risk management and program management functions to articulate technical risks and develop/manage mitigation
- Liaise with tech leads from other programs to build collective cell and gene therapy knowledge
- Engage industry to identify best practices and improvement opportunities
- BS or MS in Science/Engineering or another relevant discipline and 10+ years of experience working on process development and commercialization within a biotechnology environment.
- Experience with developing a process and analytical control strategy
- Experience with developing CMC regulatory content as author or reviewer
- Experience with cGMP Manufacturing operations and Quality Management Systems
- Experience managing complex technical programs, providing strategic direction, metrics and timelines
Vertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com.