Executive Director, Cell Therapy Process Science (MSAT)
General Summary:
This critical senior position will be responsible for building and leading the Cell Therapy Process Sciences -MSAT team within the Commercial Manufacturing and Supply Chain Division. This function is responsible for the implementation, maintenance and continuous improvement of manufacturing processes employed for commercial product release and stability for cell and genetic therapy programs. The head of this group will also cultivate and leverage multiple cross-functional business relationships to identify and execute creative solutions to organizational opportunities and challenges.
This role will report to the Head of Manufacturing Science and Technology (MSAT) within the Commercial Manufacturing and Supply Chain (CMSC) division. This technical leadership position is responsible for identifying the capabilities required and building out a diverse team focusing on developing and implementing robust and scientifically sound process control strategies for commercial products. This role partners very closely with the Process Development team in Vertex Cell and Genetic Therapies (VCGT) to ensure that robust processes are developed, transferred and validated for successful commercialization of new products and provide technical oversight during commercial manufacturing. The team is also responsible for all post-approval technical lifecycle management activities for control strategies associated with the commercial programs. This position is based in Vertex’s corporate headquarters in Boston, MA.
Key Duties and Responsibilities:
- Build a high performing team by recruiting and developing strong technical talent, ensuring the development and implementation of training required to fully qualify staff for establishing and maintaining capable and controlled processes. Lead and develop a strong winning culture, fostering teamwork and commitment to excellence through transparent communication and staff engagement. Ensure the correct capabilities, resources and teams are built and in place in order to meet the needs of the business.
- Partner closely with colleagues in VCGT to provide technical input into the design and development of robust and compliant manufacturing processes that will be transferred into commercial manufacturing. Critically, the team will play a leadership role in developing the strategy and content for CMC regulatory filings for the overall process control strategy for commercializing new programs and maintenance through the product lifecycle.
- Lead the transfer and validation of processes into commercial manufacturing facilities and CDMOs for late stage programs to support commercialization, as well as post-approval transfers to new sites. Provide technical support for complex technical issue resolution for commercial manufacturing, such as support for complex technical deviations and investigations. This team will also lead the trending and continuous process verification of the process data for all CGT programs and establish a continuous improvement agenda to improve outcomes.
- Lead the design, development and implementation of comprehensive product technical agendas, including next generation processes and technologies for post-approval lifecycle management. This will include working closely with cross-functional teams in VCGT, Regulatory Affairs, Supply Chain and Manufacturing Operations to ensure alignment.
- Build out appropriate laboratory capabilities required to provide technical support for commercial processes, as well providing technical support for complex process-related investigations and next generation technology development.
- The incumbent would be expected to be active and influential in the external landscape, monitoring technical and regulatory developments in process technologies and CMC and be an industry-recognized thought leader in the space.
- Champion the culture of quality and ensure that all activities and documentation comply with regulatory requirements. Understand and implement processes, controls, and methods that align with global Health Authority regulatory expectations. Drive operational excellence, flawless execution and continuous improvement.
- 20% travel expected.
Knowledge and Skills:
- Experience with Biological products and/or Genetic and Cell Therapy technologies is critical. The incumbent would be expected to be a thought leader within the space of process technologies and have a proven ability to innovate and implement practical solutions.
- Deep technical understanding of process science that support commercial manufacturing activities. Demonstrated understanding of the principles and applications associated with commercial manufacturing operations for biological and/or cellular and genetic therapies.
- A proven ability to work seamlessly across teams and develop excellent relationships and partnerships with peers is critical to success in this role.
- Strong knowledge of cGMP requirements.
- A strategic thinker with strong result-orientation and a sense of urgency to deliver quality results on time and in a highly ethical and professional manner.
- Strong understanding of the technical aspects of manufacturing, testing, and controls and regulations governing pharmaceutical operations.
- Motivational leadership of a cohesive high-performing team within a global, highly matrixed environment; the ability to articulate vision and successfully drive execution.
- Excellent communication and interpersonal skills with the ability to build strong cross-functional relationships and communicate complex issues and concepts enterprise-wide.
- Excellent team player and be able to build and sustain organization respect and trust at all levels.
- Problem solver with a hands-on approach and ability to anticipate adverse scenarios and provide contingency plans to address them.
- Resilient and able to work well in a demanding, fast paced entrepreneurial environment.
- Sound judgment and business acumen with personal versatility and flexibility as business and team evolve.
- Keeps current on professional knowledge, expertise and best practice.
Education and Experience:
- PhD in biological or engineering disciplines with 12-15 years of relevant experience in biotech/ pharmaceutical industry OR
- MS/MA degree in Biological Sciences, Chemistry, microbiology or related discipline and at least 14 years of related experience; or PhD degree in Biological Sciences, Chemistry, microbiology or related discipline and at least 12 years of related experience.
- 12-15 years progressive experience in key technical leadership roles in process development and commercial manufacturing.
Flex Designation:
On-Site Designated
Flex Eligibility Status:
In this On-Site designated role, you will 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.
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