CMC Product Leader, Senior Director - Biologics

Job Description

The Senior Director, CMC Product Leader, Biologics, will lead CMC functional teams of one or multiple biologics products. This role involves managing all CMC-related activities, ensuring the development, scale-up, and commercialization of high-quality biologics 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 biologics process development, 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 biological products.

• 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 internal CMC FT members from BiopharmSci and CDMO partners.

• Manage technology transfer to or between CDMO 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 internal cross-functional CMC teams, joint project teams with CDMOs 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 biologics.

• 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 biologics products.

• In-depth knowledge of GMP regulations, quality assurance, and regulatory requirements for biologics products.

• Experience in managing external biologics process development and manufacturing with CDMOs is highly preferred.

• 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-fu