Associate Director, MSAT
Vertex MSAT team is seeking an Associate Director to join a growing team in support of commercial Cell and Gene Therapy programs. Reporting to the Director MSAT - Process, this position will provide key technical leadership for late-stage programs including technology transfer, validation, process design, and manufacturing support.
- Lead process fit and facility design at a CMO to enable commercial readiness.
- Collaborate cross-functionally within MSAT and Development teams to ensure continued alignment of final process design with manufacturing.
- Identify fit gaps and collaborate in developing technical solutions to enable program and company goals.
- Technical lead within a cross-functional team executing tech transfer to a CMO.
- Champion change management initiatives ensuring stakeholder consensus and alignment with business objectives.
- Provide guidance and applicable content for CMC regulatory submissions and ensure technical compliance with established conditions.
- Provide SME support for health authority inspections and post-approval CMC changes.
- Bachelor's Degree in science or related discipline is required.
- Typically requires 10 years of experience in biopharmaceutical industry with increasing responsibility, or the equivalent combination of education and experience.
- Direct experience working with CMOs to fit and transfer.
- Expertise with cell culture operation and scale-up.
- Experience with process data analysis and trending.
- Demonstrated ability to execute on projects with increasing levels of responsibility.
- Experience delivering on complex technical agendas within a high-performance team.
- Knowledge of technology transfer, process validation, process monitoring and commercial lifecycle management.
- Experience with technical support of commercial products in cGMP manufacturing including investigations and change management.
- Experience with US and EU cGMP regulations/guidance and experience with regulatory agency inspections preferred.
- Experience with developing CMC content and knowledgeable on regulatory guidance and trends.
- Ability to prioritize objectives from multiple projects, adhere to scheduled timelines while maintaining flexibility and efficiency.
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.
Please note that Vertex requires COVID-19 vaccination for all employees working in the U.S. as a condition of employment at Vertex, subject to medical, religious or other accommodations or exemptions required by law. We believe this requirement is vital to keeping everyone at Vertex and in our communities safe. This requirement applies to both existing and new employees who may at any time work on-site at a Vertex facility or visit another location on behalf of Vertex (e.g., conferences, customer visits, etc.), including all remote employees. 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 [Register to View]