Director, Process Characterization - late stage process development
Full Time
Boston, MA 02110
Posted
Job description
Job Description
Director, Cell Therapy Process Development
In June 2019, Vertex announced the establishment of a new research site in the Boston area where research, development, and clinical manufacturing for cell and genetic therapies will be 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. Further investment in a research site specifically designed to advance these programs will be key to Vertex’s continued and sustained leadership in these exciting approaches. At Vertex Cell and Genetic Therapies (VCGT) our research teams will 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.
Job Summary:
The role will be responsible for development of Vertex’s cell therapy production platforms and will participate in development of advanced cell processing and culture systems. The Director of Cell Therapy Process Development will work closely with the Analytical Development, Manufacturing and Quality Systems teams to meet program milestones. The position will be based in Boston, MA.
Key Responsibilities:
- Collaboratively develop and implement appropriate process characterization strategies leveraging DOE/QBD principles to establish appropriate process parameters
- Author CMC sections of regulatory filings
- Manage and mentor a high performing team focused on late stage development and process characterization working from upstream through downstream to final fill
- Collaborate with peer groups to effectively support tech transfer and manufacturing and overall outcomes for the program
- Reviews and approves study designs, reports, and other technical writing for technical accuracy and data integrity
- Supports investigations and identifies root causes for process issues
- Recruits and mentors talent and manages analytical sciences function with needed capabilities
Required qualifications:
- Bachelor's degree, Master’s degree or PhD in Process Development or related field in a relevant scientific discipline such as Chemical Engineering, Bioengineering, or Biochemical Engineering
- Ph.D. (or equivalent degree) and 9 years of relevant post-doctoral employment experience, or
- Masters Degree (or equivalent degree) and 12 years of relevant employment experience, or
- Bachelors Degree (or equivalent degree) and 15 years of relevant employment experience
- Demonstrated excellence in upstream process development and process characterization
- Strong understanding of phase-appropriate development
- Experience working and contributing to the strategy for late stage development as well as upstream process characterization on ideally at least two distinct programs
- Ability to communicate effectively with a diverse range of scientists and engineers
Preferred qualifications:
- Experience in adherent/suspension stem cell expansion and differentiation
- Experience in cell and/or gene therapy
- Prior experience with process transfer to >50+ liter mammalian cell culture bioreactors
- Experience with downstream process development and drug product development
- Strong knowledge of GMP requirements for cell therapy products.
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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