Scientific Director - Bioproduct R&D Upstream Process Development

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The Bioprocess Research and Development team has an exciting opportunity for an innovative scientist, technical expert 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 and various modalities (mAb, fusion proteins, bispecifics, multi-specifics, bioconjugates, ADCs, mRNA, AAV products, and etc.) at all stages of development.

Position Brand Description:

The Director/Sr Director/Executive Director of Upstream Process Development will oversee the development of drug substance Upstream Processes for biologics within Lilly’s biologics and emerging modalities portfolio. The primary responsibility will involve guiding a team of scientists and engineers to develop innovative solutions to enhance manufacturing processes for biologics pipeline and clinical phase programs. Drawing upon the extensive expertise in cell culture bioProcess Development, the successful candidate will deliver innovative approaches, drive the progression of platform processes and play a pivotal role in advancing our portfolio. Moreover, we seek a candidate deeply dedicated to fostering employee growth and who thrives within a collaborative, intellectually stimulating, and fast-paced work milieu.

Responsibilities:

• Lead and manage a proficient team of scientists and engineers accountable for Upstream Process Development endeavors. These encompass various activities such as process design, optimization, characterization, scale-up, scale-down modeling, technology transfer, and addressing process troubleshooting. The focus will be on supporting a diverse biologics portfolio, including novel modalities, across early- and late-stage clinical development.
  • Advance upstream platform process technical strategy and capabilities for different modalities; drive and define creative process improvement initiatives, lead a team to deliver innovations that advance technical capabilities, improve process yield, robustness, scalability for biologics production.
• Drive the progression of the upstream platform process technical agendas and enhance capabilities for diverse modalities. Spearhead process innovation initiatives, overseeing a team tasked with delivering innovations that elevate technical capacities, enhance process yield, robustness, and scalability for biologics production.
• Act as an upstream development subject matter expert, providing pivotal technical guidance for Process Development, characterization, and commercialization initiatives. This oversight ensures a seamless path towards successful regulatory submissions for our portfolio.
• Author and review CMC documentation including CMC sections of regulatory submissions, technical reports crucial for filing and responding to questions from regulatory submissions.
• Cultivate robust cross-functional collaborations within Development organizations and establish effective partnerships with Discovery, Manufacturing, and external entities, that are vital for product development and integration of new technologies.
• Provide supervision, coaching, and mentorship to junior scientists and engineers, fostering their growth and development within the team.

Basic Qualifications

• PhD in Chemical Engineering, Biotechnology/ Biological Engineering, Biology, Chemistry/Biochemistry, or related field.
• 8+ years of industry experience in mammalian cell culture Process Development is a must have. Demonstrated competency, experience, and knowledge in biologics CMC development and compliance requirements from early to late clinical phase programs.

Additional Skills/Preferences:

• Subject matter expertise in Upstream Process Development, including extensive hands-on experience with cell culture Process Development.
• Expertise with variety of cell culture processing platforms and production systems (mammalian, insect, bacterial).
• Direct experiences in supporting regulatory submissions (INDs/BLAs) for various types of therapeutics especially new modalities is highly desired.
• Proven ability to work cross functionally, effectively plan and organize work activities and prioritize to meet schedules and deadlines.

Additional Information:

• Location: Indianapolis, IN
• Travel: Up to 5%

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