Vertex Pharmaceuticals
Boston, Massachusetts, United States
(on-site)
6 days ago
Job Type
Full-Time
Job Function
Other / Not Listed

Description

Job Description

The Senior Director, CMC Product Leader for Biopharmaceutical Sciences-Cell & Gene Therapy, will lead the CMC functional team dedicated to a single cell therapy or biological product. This role involves managing all CMC-related activities, ensuring the development, scale-up, and commercialization of high-quality cell therapy 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 cell therapy 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 the cell therapy or other biological product.
  • 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 CMC FT members from BiopharmSci.
  • Manage technology transfer to 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 cross-functional meetings 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 cell therapy or regenerative medicine.
  • 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 cell therapy products.
  • In-depth knowledge of GMP regulations, quality assurance, and regulatory requirements for cell therapy products.
  • 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.


  • 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 atApplicationAssistance@vrtx.com.

    Job ID: 74276172

    At Vertex, we bring together the brightest minds in the relentless pursuit of creating transformative medicines for people with serious and life-threatening diseases. Founded in 1989 in Cambridge, Massachusetts, we are one of only a handful of biotechnology companies founded since 1976 that has discovered and developed four or more approved medicines in our own labs. In addition to the four medicines we’ve developed to treat the underlying cause of cystic fibrosis, we have ongoing research programs focused on the underlying ...

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