Director Late Phase Process Development SMDD

Eli Lilly and Company • Us, IN

12h • 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. The Director Late Phase Process Development will lead late-phase synthetic molecule process development, including finalizing commercial routes and processes, characterizing processes, and establishing control strategies that support Phase 3 clinical supply, registration stability, regulatory submissions, process validation, and commercial handoff.

The role leads cross-disciplinary teams that may include process chemists, analytical chemists, material scientists, and engineers. It also provides oversight for external R&D, technology transfer, and campaign execution. The position is based at Lilly Technology Center-North in Indianapolis, Indiana, with potential exposure to chemicals, allergens, and loud noises and travel of 0 to 20%.

The anticipated annual wage is $153,000–$264,000. Full-time equivalent employees are eligible for a company bonus, depending in part on company and individual performance. Lilly also describes a comprehensive benefits program for eligible employees, including 401(k), pension, vacation, medical, dental, vision and prescription drug coverage, flexible benefits, life insurance and death benefits, certain time-off and leave benefits, and well-being benefits.

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.

Nice To Haves

• Experience in the pharmaceutical sector; other experience may also meet expectations.
• Experience in active-ingredient development and associated formulated products.
• Experience developing chemical processes for small-molecule projects from Phase 3 through commercialization.
• Experience transferring processes into manufacturing operations.
• Experience authoring regulatory submissions and responding to regulatory questions.
• Established external reputation and a strong publication record.
• 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 and lead 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, good communication, and sustained collaboration.
• Ability to prioritize multiple activities and handle ambiguity.
• Ability to influence others and promote a positive work environment.

Responsibilities

• Apply expertise in modern synthetic organic and process chemistry to address key CMC challenges.
• Lead or supervise the finalization of commercial synthetic routes and the development of robust, scalable, well-characterized API manufacturing processes, including starting-material selection and commercial-route justification.
• Design laboratory experimental plans supporting route and process design, definition, optimization, and technology transfer.
• Apply learning agility to understand and use scientific concepts and methods across multiple fields and a changing portfolio of small-molecule programs.
• Apply knowledge of unit-operation design and scale-up methodologies, and develop technology and platforms within time-constrained environments.
• 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 CRO/CMO organizations 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; develop and apply mechanistic, kinetic, and data-driven models to predict performance and guide development.
• 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 diverse scientific staff; encourage initiative, accountability, knowledge sharing, and collaboration on challenging technical issues.
• Collaborate with and influence the external scientific community, recognizing and integrating external innovation across Lilly’s synthetic portfolio.

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.
• Employee resource groups (ERGs) that provide support networks and are open to all employees.

What This Job Offers

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