Associate Director, Process Development Core
Vertex has established a new research site in the Boston Seaport where research, development, and clinical manufacturing for cell and genetic therapies is primarily based. Cell and genetic therapies represent two rapidly emerging therapeutic modalities with the potential to treat—and even cure—several of the diseases Vertex is focused on, including sickle cell disease, Duchenne muscular dystrophy and type 1 diabetes. Investment in a research site specifically designed to advance these programs is key to Vertex’s continued and sustained leadership in these exciting approaches. At Vertex Cell and Genetic Therapies (VCGT) our research teams bring together the best biology, technologies, and enhanced manufacturing capabilities to ensure we bring these cutting-edge transformative therapies to patients as quickly as possible.
Vertex is seeking a talented individual to join our Process Development /Engineering team. This group offers a dynamic, fast-paced, and highly collaborative environment making tremendous impact on our programs and for our patients. Our team focuses on bringing together the best of process design, scale-up and cutting-edge manufacturing technologies to enable the successful implementation of cell and gene therapeutics.
This newly created position will be responsible for establishing a centralized function that provides technical support to all Cell and Gene Therapy Process Development and Research teams. This includes provision of high quality media, process intermediates and final product to help advance portfolio programs. This role will be responsible for supplying high quality material as per business need and establish a lab-based training program to onboard new team members. This is a highly integrated role working across several functions including Process Development, Analytical Development and Research
Key Duties and Responsibilities:
- Establish lab capabilities for producing allogenic and autologous cell therapy process intermediates and DS/DP material using established procedures
- Set-up a continuous supply of seed culture, process intermediate and DS/DP to Research and Process Development teams as per business need
- Progress already established vector core production lab to supply small scale AAV batches to Research and Process Development team
- Establish centralized supply of raw materials such as buffers, media, and process solutions to process development teams through a combination of internal and external sources
- Develop a lab-based training program for cell and gene therapy processes to onboard new scientists and engineers
- Develop and refine procedures for cell therapy and viral vector processing that can be transferred to PD teams
- Actively engage with all stakeholder groups in Process Development, Analytical Development and Research to understand business needs and develop integrated solution for material supply
- Evaluate new technologies and operational ideas to continuously improve efficiency and quality
- Manage a team of scientists and technicians to support business need
Required Experience Level:
- Masters or advanced degree in Biochemical Engineering, Biochemistry or relevant filed
- MS degree and 10+ years of experience (or PhD and 7+ years) in biotechnology industry with 5+ of direct experience in managing a core capability function for biologics or cell/gene therapy
- Expertise in mammalian cell culture, harvest and clarification operations and downstream purification of biologics and/or cell and gene therapy processes at lab to pilot scale
- Hands on experience with stirred tank bioreactor process and process stream clarification and harvest technologies
- Knowledge of tangential flow filtration and chromatography applications in Cell Therapy and Viral Vector processes
- Experience in managing a lab operation to support routine production requests across multiple teams and stakeholders
- Strong verbal and written communications skills with ability to effectively network and build customer relations with all key stakeholders
- Ability to manage a diverse team consisting of scientists, technicians, and operators and support their career development
- Ability to adapt to evolving priorities and thrive in a dynamic and fast-paced environment
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.