Senior Manager, Stem Cell Process Development Engineering

Job Description

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.

VCGT is seeking a Cell Therapy Process Development Engineer/Scientist to join its growing team. 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 Cell Therapy Process Development Engineer will work closely with the Research and Development, Manufacturing and Quality Systems teams to meet program milestones. The position will be based in Boston, MA and may require periodic travel to Vertex's device production laboratories in Providence, RI,

Key Responsibilities:

• Develop robust, scaled platform for pluripotent stem cell expansion/directed differentiation and other cell types
• Develop cell isolation, purification, separation and formulation protocols and technologies in support of product development from clinical to commercial scale.
• Apply DOE/QBD principals to process characterization, establish process parameters, and contribute to CMC sections of regulatory filings
• Lead technology transfer to manufacturing and provide training for GMP production
• Serve as the Cell Culture/ Bioreactor/ Cell Therapy/ Stem Cell SME as a representative for the VCGT PD team
• Design, execute experiments using approaches such as DOE and analyze data using approaches such as MVA
• Present process analysis and trends to larger cross functional groups and leadership
• Implement a strategy for for automation and high throughput approaches to experiments in PD
• Implement a strategy for evaluation of novel technology for unit operations in PD and PAT
• Implement a documentation process for knowledge/ Tech Transfer knowledge for the T1D team
• Implement Efficiency and Ability in Prioritization of Lab Operations and Experiments

Other Duties:

• Coordinate and integrate the activities of various departments to ensure alignment in scope, schedule and budget. Ensure resources are being utilized on the most impactful activities.
• Ensure timely completion of activities needed for Investigational New Drug (IND) applications with the US Food and Drug Administration (FDA). Support the filing activities as needed.
• Partner with QA to develop and implement phase-appropriate Quality Systems for operations
• Provide and confirm user input is used for the design and commissioning of the manufacturing facility and equipment
• Identify raw materials and support the establishment of raw materials specifications.

Required Qualifications:

• PhD in Life Sciences, bio-engineering, or related discipline with minimum 6 years of relevant industrial work experience or Master's degree with 10 years of industry experience
• 2+ years management experience preferred for Sr. Manager
• 6+ years of demonstrated Process Development, Scale-Up, Process Characterization and Tech Transfer experience in a bio-pharmaceutical setting working with interdisciplinary and cross-cultural teams
• Experience working with cell processing devices and/or bioreactors
• Ability to communicate effectively with a diverse range of scientists, engineers, regulatory specialists and business professionals
• Strong Knowledge of GxP and working under regulatory environment
• Signficant experience developing processes for clinical applications
• Excellent verbal and written communication skills and ability to handle multiple tasks while meeting timelines and adapting to changing priorities.
• Strong organizational skills and high attention to details
• Authorized to legally work in US

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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.

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 (see application details).