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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

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