CMC Product Leader, Senior Director T1D

Job Description

• Develop and implement the integrated CMC strategy for assigned T1D cell therapy products ensuring alignment with product development and commercialization goals
• Lead the cross-functional CMC functional team and coordinate activities across process development analytical and method development device development when required scale-up technology transfer validation manufacturing readiness and lifecycle planning
• Serve as a key member of the Program Team providing CMC expertise and recommendations to support integrated planning milestone delivery risk management and strategic product decisions
• Partner with BiopharmSci CGTR functional leaders and subject matter experts to oversee development and optimization of robust scalable manufacturing processes that support product quality and consistency
• Guide technology transfer to manufacturing sites and support scale-up production readiness and successful execution of manufacturing activities
• Partner with Regulatory Affairs and Quality to develop CMC regulatory strategies lead preparation of CMC content for regulatory submissions and support responses to agency questions and inspections
• Ensure CMC plans and activities are consistent with applicable Good Manufacturing Practice requirements quality expectations and regulatory standards for cell therapy products
• Lead CMC project and decision approval processes through BSMO and applicable Vertex governance committees presenting clear options recommendations risks and resource implications
• Facilitate effective CMC team meetings and maintain clear communication of strategy progress decisions interdependencies risks and business needs across stakeholders
• Develop CMC budgets and resource plans in partnership with BiopharmSci functions and Finance; monitor milestones key performance indicators costs and resource utilizationProactively identify assess and mitigate technical regulatory quality supply timeline and execution risks that could affect product development or commercializationBuild strong cross-functional relationships and foster an accountable collaborative and inclusive team environment in a highly matrixed organization

• Deep knowledge of CMC development and manufacturing for cell therapy regenerative medicine or other complex biologic products
• Strong understanding of process development analytical development scale-up technology transfer process validation manufacturing and product lifecycle considerations
• In-depth knowledge of GMP requirements quality systems and global regulatory expectations relevant to cell therapy products
• Demonstrated ability to translate scientific technical regulatory and business considerations into an integrated CMC strategy and executable plan
• Strong strategic thinking judgment problem-solving and risk-management skills with the ability to make decisions in situations of uncertainty
• Proven leadership of cross-functional teams and complex programs in a matrix environment without relying solely on direct authority
• Ability to influence senior stakeholders navigate governance processes and communicate concise recommendations trade-offs and decisionsExcellent written verbal facilitation and interpersonal communication skills
• Demonstrated ability to build productive partnerships across R&D Manufacturing Quality Regulatory Clinical Commercial Finance and external organizations
• Strong financial and project management capabilities including budget resource milestone dependency and performance tracking

• Advanced degree in Chemical Engineering Biotechnology Biochemistry or a related scientific or engineering discipline. PhD or MBA preferred
• 10 years of experience in CMC development and manufacturing within the biotechnology or pharmaceutical industry with significant experience in cell therapy or regenerative medicine
• Demonstrated experience leading a function department cross-functional CMC team or major development program at the Director or Senior Director level
• Experience in process development analytical development manufacturing or a closely related CMC discipline is strongly track record supporting successful development regulatory advancement and commercialization readiness of cell therapy products
• Experience with CMC regulatory submissions and interactions with regulatory agencies
• Experience leading technology transfer scale-up validation and manufacturing readiness activities for complex products
  

At Vertex we embrace continuous learning and encourage employees to stay informed on advances in AI technology automation and industry trends. We seek talent who bring an external perspective demonstrate curiosity and sound judgment and thoughtfully adopt new capabilities that improve decision-making drive innovation increase efficiency and help deliver better outcomes for patients.

Pay Range:

Disclosure Statement:

Flex Designation:

Flex Eligibility Status:

In this Hybrid-Eligible role you can choose to be designated as:
1. Hybrid: work remotely up to two days per week; or select
2. On-Site: work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertexs Policy on Flex @ Vertex Program and may be changed at any time.

#LI-Hybrid

Company Information

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 persons 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