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　　The Bioprocess Research and Development team has an exciting opportunity for an innovative scientist, technical expert in microbial strain and fermentation process development to join our process development organization. You will be part of a diverse team of biochemists, biologists, chemical engineers, and analytical chemists to develop Lilly’s growing portfolio of therapeutic products at all stages of development.

　　Position Brand Description:

　　The Director of Upstream Process Development – Microbial Platform will oversee the development of all upstream technical activities (including microbial strain generation, fermentation/upstream process development) throughout the clinical development and commercialization of recombinant drug substance for Lilly’s biologics portfolio. The scope of the programs includes diverse therapeutic molecules that are expressed through biosynthesis from microbial fermentation process. The successful candidate will work primarily with Contract Development/Manufacturing Organizations (CDMOs) to ensure all aspects of the drug substance process development and manufacturing are completed according to Quality by Design principles and cGMP requirements. This individual should also be responsible to explore/evaluate/implement new/advanced technologies to improve microbial platforms for biotherapeutics production, and in house development activities as mandated by specific development program needs.

　　This is an exciting, intellectually stimulating opportunity, we seek a candidate with deep technical expertise and strong interest in solving technically challenging problems, advancing science and technologies, and who also thrives in a highly collaborative environment.

　　Responsibilities:

　　Provide technical assessment to enable selection of drug substance Contract Development and Manufacturing Organizations (CDMO).

　　Accountable as technical subject matter expert for all upstream drug substance upstream activities supportive of clinical development and the Biologics Licensing Applications (BLAs).

　　Work closely with CDMO partners and technical team on process design, optimization and characterization, provide technical guidance, oversight, and troubleshooting to ensure CDMO partners successfully develop a robust/efficient process, ensure timely delivery of clinical materials as per required timeline and seamless paths towards successful regulatory submissions.

　　Author and review CMC sections of regulatory submissions, technical reports crucial for filing and responding to questions from regulatory submissions.

　　unction as individual contributor working through CDMO's at first but may build/supervise a team of scientists for in house development activities as needed.

　　Basic Qualifications

　　PhD in Microbiology, Biology, Biochemistry, Chemical Engineering, Biotechnology, or related field.

　　5+ years of industry experience, additional academic research in bacterial strain and fermentation process development preferred.

　　Additional Skills/Preferences:

　　Demonstrated technical competency, experience, and knowledge in CMC development, direct experience in developing both early and late phase process development strategies, supporting successful IND submissions and BLAs is desired.

　　Subject matter expertise in strain engineering and fermentation optimization, including extensive firsthand experience with developing bacterial expression/production processes for biologics. Proven record of successful process troubleshooting, developing creative approaches/ solutions to improve microbial expression/production platform.

　　Expertise with variety of biological platforms and production systems (microbial, e.g., E. coli, yeast; mammalian; insect).

　　Upstream process development and regulatory submission experience for diverse types of biologics and new modalities in an industry setting

　　Proven ability to work cross functionally, effectively plan and organize work activities and strong adaptability to meet evolving needs as priority/clinical plan changes.

　　Demonstrated technical competency, experience, and knowledge in CMC development, direct experience in developing both early and late phase process development strategies, supporting successful IND submissions and BLAs is desired.

　　Subject matter expertise in strain engineering and fermentation optimization, including extensive firsthand experience with developing bacterial expression/production processes for biologics. Proven record of successful process troubleshooting, developing creative approaches/ solutions to improve microbial expression/production platform.

　　Additional Information

　　Location: Indianapolis, IN

　　Travel: Up to 10%

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