Director Early Phase Process Development SMDD

Eli Lilly and Company • Us, IN

4d • Onsite

About The Position

Lilly’s Synthetic Molecule Design and Development (SMDD) team develops synthetic active pharmaceutical ingredients and drug products from preclinical development through commercialization. This role leads synthetic molecule route development and unit operation definition for drug candidates supporting preclinical studies through Phase 2-enabling studies and regulatory submissions. It offers the opportunity to lead cross-disciplinary teams of process chemists, analytical chemists, material scientists, and engineers, while providing oversight for external R&D, technology transfer, and campaign execution.

The successful candidate will apply modern synthetic organic and process chemistry expertise to address CMC challenges, develop and optimize API manufacturing routes, and define experimental plans and scalable processes. The role also involves coordinating technology transfer to CRO/CMO organizations and Lilly manufacturing sites; collaborating across internal CMC functions to support clinical trials and regulatory submissions; and mentoring a diverse scientific staff. Candidates are expected to collaborate with the external scientific community and identify and apply external innovation across Lilly’s synthetic portfolio.

Requirements

• Ph.D. in organic chemistry or a related field and at least 8 years of pharmaceutical process development experience, or an M.S. in organic chemistry or a related field and at least 15 years of experience.
• Demonstrated expertise and capability in modern synthetic organic and process chemistry.
• Experience developing chemical processes for small-molecule projects from preclinical through Phase 3-enabling stages.
• Experience transferring processes into manufacturing operations.
• Demonstrated leadership, communication, collaboration, prioritization, and ability to handle ambiguity.
• Ability to influence others and promote a positive work environment.

Nice To Haves

• Pharmaceutical-sector experience; experience in other sectors may also meet expectations.
• Experience in active ingredient development and associated formulated products.
• Experience authoring regulatory submissions and responding to regulatory questions.
• Established external reputation and a strong publication record.
• Experience managing technical projects and developing ideas for future work plans.
• Experience with modern analytical techniques and process analytical technologies (PAT).
• Experience leveraging high-throughput experimental platforms to accelerate reaction discovery.
• Experience with modeling and simulation tools, data analytics, and predictive analytics.
• Ability to transform ideas into marketable products and processes.

Responsibilities

• Apply modern synthetic organic and process chemistry techniques to address key CMC challenges.
• Lead or supervise the design and development of synthetic routes for API manufacture using modern technologies.
• Design laboratory experimental plans supporting route and process design, definition, optimization, and technology transfer.
• Apply learning across scientific fields and small-molecule candidate portfolios.
• Use understanding of unit operation design and scale-up methodologies to develop technologies and platforms in time-constrained settings.
• Lead cross-disciplinary teams evaluating and refining manufacturing routes, technologies, and practices.
• Collaborate on technology transfer to CRO/CMO organizations and Lilly manufacturing sites to ensure processes are robust, characterized, and safe.
• Integrate process and property-design data using a fundamental understanding of underlying physical processes.
• Collaborate with Drug Product Delivery, Project Management, Quality, Manufacturing, and Regulatory teams to deliver materials and information for clinical trials and regulatory submissions.
• Supervise, mentor, and develop diverse scientific staff; encourage initiative, accountability, and knowledge sharing.
• Collaborate with and influence the external scientific community, recognizing and integrating external innovation into Lilly’s synthetic portfolio.
• Plan and lead short- and long-term development activities; develop or review technical agendas and project timelines, advise on resource allocation, communicate progress, and propose changes to project plans.

Benefits

• Company bonus, depending in part on company and individual performance.
• Eligibility to participate in a company-sponsored 401(k).
• Pension.
• Vacation benefits.
• Eligibility for medical, dental, vision, and prescription drug benefits.
• Flexible benefits, including healthcare and/or dependent day-care flexible spending accounts.
• Life insurance and death benefits.
• Certain time-off and leave-of-absence benefits.
• Well-being benefits, including an employee assistance program, fitness benefits, and employee clubs and activities.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree