CMC Product Leader, Senior Director - T1D

Job Description

General Summary:

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 utilizationProactively identify, assess, and mitigate technical, regulatory, quality, supply, timeline, and execution risks that could affect product development or commercializationBuild 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 decisionsExcellent 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:

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.

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

About Vertex

Help Us Achieve Our Mission

Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases and conditions. The company has approved therapies for cystic fibrosis, sickle cell disease, transfusion-dependent beta thalassemia, acute pain and acromegaly, and it continues to advance clinical and research programs in these areas. Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including IgA nephropathy, neuropathic pain, APOL1-mediated kidney disease, primary membranous nephropathy, congenital adrenal hyperplasia, ACTH-dependent Cushing's syndrome, autosomal dominant polycystic kidney disease, type 1 diabetes, generalized myasthenia gravis, and myotonic dystrophy type 1.

Vertex was founded in 1989 and has its global headquarters in Boston, with international headquarters in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia, Latin America and the Middle East. Vertex is consistently recognized as one of the industry's top places to work, including 16 consecutive years on Science magazine's Top Employers list and one of Fortune’s 100 Best Companies to Work For. For company updates and to learn more about Vertex's history of innovation, visitwww.vrtx.com or follow us on LinkedIn, Facebook, Instagram, YouTube, and X

We believe our culture is one of Vertex’s greatest strengths and a key enabler of our ability to deliver transformative medicines for patients who need them. Rooted in innovation, purpose and collaboration, our culture empowers people to take smart risks, challenge conventional thinking and do their best work. The diversity of our people is central to that culture. By bringing together individuals with different backgrounds, experiences and perspectives, we foster an environment where new ideas thrive, better decisions are made and breakthrough innovation is possible. We are committed to creating a workplace where everyone feels valued, included and connected to our shared mission, because we know that our unique culture and the collective strength of our people are what set Vertex apart.