Director Early Phase Process Development SMDD

Lilly • Indianapolis, IN

1d • $153,000 - $264,000 • Onsite

About The Position

The Synthetic Molecule Design and Development (SMDD) team develops synthetic active pharmaceutical ingredients from preclinical phases through commercialization of drug substances and drug products. The team applies expertise across chemistry, engineering, and science to advance technical and business solutions and accelerate drug development.

The Director Early Phase Process Development will lead synthetic molecule route development and define unit operations for drug candidates, supporting preclinical studies through Phase 2-enabling studies and regulatory submissions. The role leads multidisciplinary teams of process chemists, analytical chemists, material scientists, and engineers, and provides oversight for external research and development, technology transfer, and campaign execution. The position is based at Lilly Technology Center-North in Indianapolis, Indiana, with 0–10% travel and potential exposure to chemicals, allergens, and loud noises.

Requirements

• Ph.D. in organic chemistry or a related field with at least 8 years of pharmaceutical process development experience, or an M.S. in organic chemistry or a related field with at least 15 years of experience.
• Demonstrated expertise in modern synthetic organic and process chemistry techniques.
• Experience designing and developing synthetic routes and chemical processes for small-molecule candidates.
• Knowledge of unit-operation design and scale-up methodologies.
• Demonstrated leadership capabilities, communication skills, and sustained 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.
• Experience developing chemical processes for preclinical through Phase 3-enabling small-molecule projects.
• Experience transferring processes into manufacturing operations.
• Experience authoring regulatory submissions and responding to regulatory questions.
• Established external reputation and a strong publication record.
• Experience managing technical projects and building 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

• Demonstrate deep expertise in modern synthetic organic and process chemistry techniques to address CMC challenges.
• Lead or supervise the design and development of synthetic routes for API manufacture using modern technologies.
• Design experimental laboratory plans to support route and process design, definition, optimization, and technology transfer.
• Apply new scientific concepts and methods across multiple fields and small-molecule candidates.
• Apply knowledge of unit-operation design and scale-up, developing and using technology and platforms in a time-constrained environment.
• Lead cross-disciplinary teams evaluating and refining manufacturing routes, technologies, and practices across the portfolio.
• Collaborate on technology transfer to CRO/CMO organizations and internal Lilly manufacturing sites to ensure processes are robust, characterized, and safe.
• Integrate process and property-design data using an understanding of underlying physical processes.
• Collaborate with internal CMC groups, 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, 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 timelines, advise on resource allocation, communicate progress, and propose changes to project plans.
• Manage technical projects and develop ideas for future work plans.
• Use modern analytical techniques, process analytical technologies, high-throughput experimental platforms, modeling and simulation tools, data analytics, and predictive analytics to advance development.
• Transform ideas into marketable products and processes.
• Prioritize multiple activities, handle ambiguity, communicate effectively, collaborate, and influence others to promote a positive work environment.

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