Cell Process Dev Engineering Sr. Scientist

Job Description

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
• Implement automation and high throughput approaches to experiments in PD
• Initiate evaluation of novel technology for unit operations in PD and PAT
• Generate and document process 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, Bioengineering, Biochemical/Biomedical Engineering or related discipline with minimum 4 years of relevant industrial work experience or a Master's degree in relevant field with 6 years of relevant industry experience or Bachelor's degree in relevant field with 8 years of relevant industry experience
• 1-2 years management experience preferred
• 4+ 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
• Working knowledge of GxP and working under regulatory environment
• 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

Preferred Qualifications:

• Experience in stem cell expansion and differentiation
• Demonstrable productivity in the form of patents, publications and/or presentations.
• Prior experience with bench scale (2+ liter) to large scale (50+ liter) mammalian cell culture bioreactors
• Experience with cell separation/selection devices
• Strong knowledge of GMP requirements for cell therapy products.

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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. 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.