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

• 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.
• 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.
• 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.
• 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.
• 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.
• 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-functional relationships.
• Experience with regulatory submissions and interactions with regulatory agencies.

Pay Range

$237,700 - $356,600

Disclosure Statement

The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.

At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.

Flex Designation

Hybrid-Eligible Or On-Site Eligible

Flex Eligibility Status

In this Hybrid-Eligible role, you can choose to be designated as:

• Hybrid: work remotely up to two days per week; or select
• On-Site: work five days per week on-site with ad hoc flexibility.

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

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 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