Director Late Phase Process Development SMDD

Lilly • Indianapolis, IN

2d • $153,000 - $264,000 • Onsite

About The Position

The Synthetic Molecule Design and Development (SMDD) team develops synthetic active pharmaceutical ingredients from preclinical development through commercialization. The team brings together chemists, engineers, and scientists to develop technical and business solutions across Lilly’s portfolio.

The Director Late Phase Process Development will lead late-phase synthetic molecule process development, including finalizing commercial routes and processes, characterizing processes, and defining control strategies. The work supports Phase 3 clinical supply, registration stability, regulatory submissions, process validation, and commercial handoff. The role leads multidisciplinary teams of process chemists, analytical chemists, material scientists, and engineers, and provides oversight for external R&D, technology transfer, and campaign execution.

The position is located at Lilly Technology Center-North in Indianapolis, Indiana. Travel is 0 to 20%. Potential workplace exposures include chemicals, allergens, and loud noises.

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.
• Experience developing chemical processes for Phase 3 through commercialization of small molecule projects.
• Experience transferring processes into manufacturing operations.
• Experience authoring regulatory submissions and responding to regulatory questions.
• Knowledge and experience managing technical projects and developing ideas for future work plans.
• Experience with modern analytical techniques and process analytical technologies (PAT).
• Experience applying Quality by Design (QbD), design of experiments (DoE), and risk assessments to establish process understanding, proven acceptable ranges, and design space.
• Ability to plan short- and long-term development activities; develop or review technical agendas and timelines; advise on resource allocation; communicate progress; and propose changes to timelines, objectives, or direction.
• Experience with modeling and simulation tools, data analytics, predictive analytics, and AI/ML.
• Ability to transform ideas into marketable products and processes.
• Demonstrated leadership capabilities, strong communication skills, and a sustained tendency toward collaboration.
• Ability to prioritize multiple activities and 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.
• An established external reputation and strong publication record.

Responsibilities

• Apply expertise in modern synthetic organic and process chemistry to address CMC challenges.
• Lead or supervise the finalization of commercial synthetic routes and development of robust, scalable, well-characterized API manufacturing processes, including selection and justification of starting materials and the commercial route.
• Design laboratory experimental plans supporting route and process design, definition, optimization, and technology transfer.
• Apply learning agility and scientific concepts across fields to a dynamic portfolio of small molecule programs.
• Apply knowledge of unit operation design and scale-up methodologies and develop technologies and platforms within time constraints.
• Use risk-based process characterization, design space definition, and control strategy development to prepare for process validation and commercial manufacture.
• Use predictive modeling, simulation, and machine learning to inform design space definition, impurity fate and purge, scale-up, and control strategies.
• Lead cross-disciplinary teams to refine manufacturing routes and technologies across the small molecule portfolio.
• Deliver commercial-ready manufacturing processes, including impurity control, process robustness, and lifecycle strategy, and enable handoff to internal and external commercial manufacturing sites.
• Collaborate on technology transfers to CROs, CMOs, and internal Lilly manufacturing sites to ensure processes are robust, well developed, characterized, and safe.
• Integrate process and property data with understanding of underlying physical processes, and build or apply mechanistic, kinetic, and data-driven models to predict performance and guide development decisions.
• Use artificial intelligence and machine learning tools to accelerate development and deepen process understanding.
• Collaborate across internal CMC networks, including Drug Product Delivery, Project Management, Quality, Manufacturing, and Regulatory, to deliver materials and information for clinical trials and regulatory submissions.
• Supervise, mentor, and develop a diverse scientific staff; encourage initiative, accountability, knowledge sharing, and contributions to resolving technical challenges.
• Collaborate with and influence the external scientific community, recognizing and integrating external innovation across Lilly’s synthetic portfolio.

Benefits

• Company bonus eligibility, 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