Process And Analytical Development Scientist

Enzyvant is a biotechnology company dedicated to developing novel, transformative regenerative therapies for people with devastating rare diseases. Enzyvant’s lead asset is the investigational tissue-based regenerative therapy, RVT-802, for congenital athymia, an ultra-rare and life-threatening pediatric immunodeficiency. RVT-802 has been granted multiple regulatory designations, including the US Food and Drug Administration expedited designation as a Regenerative Medicine Advanced Therapy (RMAT).

Enzyvant is part of Sumitovant Biopharma (wholly owned by Sumitomo Dainippon Pharma), a global ecosystem of companies working on innovative research and development activities to transform healthcare and improve the lives of people worldwide. This global ecosystem has a geographic footprint spanning Japan, the US, China and the EU as well as talent, knowledge and resources across a wide spectrum of technologies and therapeutic areas.

The Process and Analytical Development Scientist will be a key member of the CMC team. They will be responsible for helping establish the newly created Enzyvant Analytical and Process Development laboratory and driving process and analytical development initiatives.

The Process and Analytical Development Scientist will have a lead role in processing human thymus tissue to support development activities. The candidate must have expertise in cell culture, tissue culture (preferred), or processing tissue for regenerative medicine. This role will design and lead studies aimed at process improvements for the slicing and culturing of human organs.

You will:

• Manufacture non-GMP cultured thymus tissue in the process development lab
• Lead process development activities for cultured thymus tissue to increase the yield and quality of the final product
• Act as a subject matter expert (SME) for the tissue culture process during technology transfers, investigations, and regulatory submissions
• Be an active member of the process and analytical method development team
• Train new staff, including manufacturing personnel

Qualifications

• Ability to design and execute process development studies for tissue-based products and produce high-quality reports describing the results
• Experience with mammalian cell culture or tissue culture is required. Experience with cellular or tissue-based therapeutic products is a plus
• BS, MS or PhD degree in the life sciences, chemistry or biochemistry, or related field
• Ability to work as part of a team

Skills

• Excellent verbal and written communication skills
• Ability to present scientific results effectively
• Must have very good aseptic technique

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