CMC Product Leader, Senior Director - T1D

Vertex Pharmaceuticals Incorporated; Boston (MA); Hybrid; USD 238,000 - 357,000; Full time

Job summary

Vertex Pharmaceuticals Incorporated is seeking a Senior Director, CMC Product Leader (T1D) to lead the CMC team for cell therapy programs, shaping development strategies, technology transfer, and regulatory readiness.

The role partners across BiopharmSci CGT, Manufacturing, Quality, Regulatory and Clinical to ensure GMP-compliant processes, scalable manufacturing, and timely submissions, with strong governance and budget oversight.

Qualifications

• Advanced degree and 10+ years in CMC development and manufacturing.
• Experience leading CMC programs and regulatory submissions.
• Strong cross-functional collaboration and program governance.

Responsibilities

• Develop and implement the integrated CMC strategy for assigned T1D cell therapy products.
• Lead cross-functional CMC team across development, analytical/ process development, scale-up, tech transfer, validation, and lifecycle planning.
• Serve on the Program Team to support planning, milestones, risk management, and decisions.
• Oversee development and optimization of scalable manufacturing processes for product quality and consistency.
• Guide technology transfer to manufacturing sites and support scale-up and readiness.
• Partner with Regulatory Affairs and Quality to develop CMC regulatory strategies and submissions.

Skills

CMC strategy

Cross-functional leadership

Regulatory and quality awareness

Risk management

Financial & project management

Stakeholder influence

Communication skills

Education

Advanced degree in Chemical Engineering/ Biotechnology

PhD or MBA preferred

Job description

Job Description

The Senior Director, CMC Product Leader (T1D) will lead the Chemistry, Manufacturing, and Controls (CMC) functional team supporting cell therapy products within Biopharmaceutical Sciences - Cell & Gene Therapy. The role is accountable for developing and executing integrated CMC strategies across development, scale-up, technology transfer, validation, regulatory submission, and commercialization readiness. As the CMC representative on the Program Team, a sub-team of the Disease Strategy Team, the CMC Product Leader will partner across BiopharmSci CGT, Manufacturing, Quality, Regulatory, Clinical, Commercial, Finance, and other functions to align CMC plans with broader product objectives. The successful candidate will provide strategic and technical leadership, guide governance and decision-making, manage program risks and resources, and enable delivery of high-quality cell therapy products.

Key Duties and Responsibilities

• 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 utilization. Proactively identify, assess, and mitigate technical, regulatory, quality, supply, timeline, and execution risks that could affect product development or commercialization. Build strong cross-functional relationships and foster an accountable, collaborative, and inclusive team environment in a highly matrixed organization

Knowledge and Skills

• 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 decisions


• Excellent 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

Education and Experience

• 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 preferred. Proven 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

$237,700 - $356,500

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.

Note: The Flex status for this position is subject to Vertex's 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 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 [e-mail].