Process Development Engineering Scientist - Cell Therapy

Job Description

General Summary:

The Process Dev Engineering Scientist will be part of a team responsible for the development, optimization, and characterization of drug product manufacturing processes for cell-based products and combination products. This is a lab-based role focusing on formulation development, process development, scale-up, tech transfer, and evaluation of next generation drug product platforms.

Key Duties And Responsibilities

• Conceives, designs, and executes studies in support of drug product process development and characterization for cell-based products and combination (device) products, including aseptic fill-finish process development, formulation, stability, compatibility
• Develops robust, scalable platforms and processes in support of product development from clinical to commercial scale
• Evaluates novel and emerging technologies for process optimization
• Leads technology transfer to manufacturing and provides guidance, training, and oversight for GMP production
• Authors technical protocols and reports, contributes to CMC sections of regulatory filings
• Analyzes and presents data to cross-functional project teams
• Periodic weekend coverage may be required
  
  

Knowledge And Skills

• Hands-on experience in aseptic technique and cell culture
• Expertise and hands-on experience in at least one of the following areas: 1) Cell therapy process development; 2) Media development or formulation development; 3) Cryogenic or hypothermic cell preservation; 4) Aseptic fill-finish process development; 5) Combination product development
• Working knowledge of cell-based analytical assays
• Experience in design of experiments (DOE) and statistical analysis
• Developed communication skills to exchange technical/scientific information
• Demonstrated ability to independently plan and execute studies in the laboratory
• Ability to build collaborative relationships and work effectively as a member of a multidisciplinary team
  
  

Education And Experience

• PhD in Stem Cell Biology, Chemical/Biochemical/Biomedical Engineering or related discipline with 0-2 years of industry experience, a MS degree with 5+ years of industry experience, or a BS degree with 6+ years of industry experience
• Direct industry experience developing cell therapies for early and/or late phase clinical trials
• 1
  
  

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.