CMC Product Leader, Senior Director - Biologics

Senior Director, CMC Product Leader, Biologics

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 Vertexs 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 :

3. Process Development and Manufacturing :

4. Regulatory Compliance and Quality Assurance :

5. Cross-Functional Collaboration :

6. Financial and Project Management :

Qualifications :

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 : 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.

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.