Director Process Chemistry SMDD

Position Summary

Our team is looking for experienced and creative individuals to lead synthetic molecule route commercialization as well as process optimization and unit operation definition of drug candidates to support clinical trials, product commercialization, and regulatory submissions. This is an opportunity to lead dynamic teams comprised of process chemists, analytical chemists, formulation scientists, and engineers. Candidates will provide oversight for external R&D, tech transfer, and campaign execution.

• Demonstrate a deep expertise and demonstrated capability with utilization of modern synthetic organic and process chemistry techniques to address key CMC challenges.
• Lead and/or supervise the design and development of new synthetic routes for the manufacture of API using the most modern technologies.
• Exhibit a high learning agility with the ability to understand and exploit new scientific concepts and methods across multiple fields; apply takeaways to a portfolio of small molecule, oligonucleotide, synthetic peptide, and other emerging synthetic modalities.
• Possess solid understanding in unit operation design, process modeling, equipment selection, and scale‑up methodologies; build and apply groundbreaking technology and novel platforms within a time‑constrained environment.
• Lead a cross‑disciplinary team to evaluate and refine new manufacturing routes, technologies, and practices to deliver an exciting portfolio.
• Provide technical leadership in the scale‑up and demonstration of new chemical processes in development and commercial scale equipment; collaborate in technology transfer activities to CRO/CMO organizations and internal Lilly manufacturing nodes to ensure processes are technically robust, well‑developed, characterized, and safe.
• Design experimental laboratory plans in support of route and process design, definition, optimization, and technology transfer objectives.
• Integrate process (and property design) data based on a fundamental understanding of underlying physical processes.
• Apply advancements in technology (PAT) and modeling platforms to understand and lead experimental protocols.
• Leverage high‑throughput experimental platforms to accelerate reaction discovery.
• Plan and lead short‑term and long‑term development activities; develop and/or review technical agendas and timelines for project work; advise resource allocation to accomplish projects according to plans, communicate progress and propose changes in timeline, objectives, or direction.
• Collaborate across internal CMC networks (Drug Product Delivery, Project Management, Quality, Manufacturing, and Regulatory) to implement and deliver material and information for clinical trials and regulatory submissions.
• Possess deep understanding of the external global regulatory climate and emerging requirements; address key CMC regulatory questions that enable clinical studies and support marketing authorization applications.
• Embrace diversity in thoughts, background, and experiences through supervision, mentoring, and development of a diverse scientific staff to deliver solutions.
• Encourage team members to take initiative and accountability to achieve goals and draw out shared knowledge on challenging technical issues.
• Actively collaborate and exhibit influence in the external scientific environment and recognize and integrate external innovation across the Lilly synthetic portfolio.

• Ph.D. in organic chemistry, or a related field with 10+ years of pharmaceutical process development experience; OR MS in Organic Chemistry or related field with 15+ years’ experience.
• Experience with in the pharmaceutical sector is preferred; other experience may meet expectations.
• Prior experience in active ingredient development and associated formulated product is acceptable.
• Experience with developing chemical processes from mid‑development cycle (proof of concept) to product commercialization.
• Experience with technical transfer of processes into manufacturing operations.
• Experience with authoring regulatory submissions and responding to regulatory questions.
• Established external reputation and strong publication record.
• Know…