Job Description

The Senior Director, CMC Product Leader for Biopharmaceutical Sciences-Cell & Gene Therapy, will lead the CMC functional team dedicated to a single cell therapy or biological product. This role involves managing all CMC-related activities, ensuring the development, scale-up, and commercialization of high-quality cell therapy products. The successful candidate will be an integral part of the Product Team (PT), which operates as a sub-team of the Disease Strategy Team (DST). This position requires strong expertise in cell therapy manufacturing, regulatory compliance, and cross-functional collaboration to drive product success.

The individual will report into the Executive Director, Project Management and Strategic Operations for Biopharmaceutical Sciences-CGT. It will be based at Vertex’s Leiden Center location in Boston, MA and will be a hybrid eligible role with expectation of a minimum of three days onsite.

Key Responsibilities:

1. CMC Leadership:

• Develop and implement CMC strategies specific to the cell therapy or other biological product.
• Lead the CMC functional team (FT), overseeing process, method, and device development, scale-up, technology transfer, and validation.
• Ensure alignment of CMC activities with overall product development and commercialization goals.

2. Product Team (PT) Participation:

• Serve as a key member of the Product Team (PT), contributing to cross-functional planning and decision-making.
• Collaborate with other PT members, including clinical, regulatory, commercial, and quality teams, to achieve product milestones.
• Provide CMC expertise and insights to support strategic product decisions within the PT.

3. Process Development and Manufacturing:

• Oversee the development and optimization of manufacturing processes to ensure product quality, consistency, and scalability, by partnering with CMC FT members from BiopharmSci.
• Manage technology transfer to manufacturing sites, ensuring seamless scale-up and production readiness
• Ensure compliance with Good Manufacturing Practices (GMP) and other relevant regulatory standards.

4. Regulatory Compliance and Quality Assurance:

• Develop CMC regulatory strategies and lead the preparation of CMC sections for regulatory submissions.
• Collaborate with regulatory affairs to address CMC-related queries and inspections from regulatory agencies.
• Implement robust quality control and assurance systems to maintain product integrity and compliance.

5. Cross-Functional Collaboration:

• Responsible for ensuring project and decision approval processes through BSMO and Vertex governance committees.

• Work closely with R&D, clinical, regulatory, and commercial teams to ensure cohesive and integrated product development.
• Facilitate communication and alignment between CMC activities and broader product development objectives.
• Lead cross-functional meetings and ensure clear communication of CMC progress, challenges, and needs.

6. Financial and Project Management:

• Develop budgets for project CMC activities, in collaboration with BiopharmSci functions and Finance, ensuring efficient use of resources.
• Track and report on key performance indicators (KPIs) and project milestones.
• Identify and mitigate risks to ensure timely and successful product development and commercialization.

Qualifications:

• Advanced degree in Chemical Engineering, Biotechnology, Biochemistry, or a related field; PhD or MBA preferred.
• Minimum of 10 years of experience in CMC development and manufacturing within the biotechnology or pharmaceutical industry, with a focus on cell therapy or regenerative medicine.
• Preference for individuals with experience leading a function or department in Process Development, Analytical Development, or Manufacturing at a Director or Senior Director level
• Proven track record of successful CMC development and commercialization of cell therapy products.
• In-depth knowledge of GMP regulations, quality assurance, and regulatory requirements for cell therapy products.
• Strong strategic thinking and problem-solving skills.
• Excellent leadership and team management capabilities.
• Outstanding communication and interpersonal skills.
• Demonstrated ability to work effectively in a matrix environment and build strong cross-functional relationships.
• Experience with regulatory submissions and interactions with regulatory agencies.

Company Information