Director Early Phase Process Development SMDD

Eli Lilly and Company; Indianapolis (IN); On-site; USD 153,000 - 264,000; Full time

Benefits offered by this job

401(k)

Pension

Vacation benefits

Medical, dental, vision benefits

Job summary

Lilly in Indianapolis seeks experienced scientists to lead synthetic molecule route development and unit operation definition for preclinical to Phase 2 studies. You will guide teams of process chemists, analytical chemists, and engineers to advance drug candidates and support regulatory submissions.

The role includes oversight of external R&D, tech transfer, and campaign execution. Strong expertise in modern analytics, PAT, and scale-up is essential to deliver robust manufacturing processes.

Qualifications

• Ph.D. in organic chemistry or related field with 8+ years of process development experience OR MS with 15+ years' experience.
• Experience with regulatory submissions and responses to regulatory questions.

Responsibilities

• Lead synthetic molecule route development and unit operation definition for drug candidates.
• Provide oversight for external R&D, tech transfer, and campaign execution.
• Collaborate across CMC networks to support clinical trials and regulatory submissions.

Skills

Process chemistry

Regulatory submissions

Team leadership

Analytical techniques

PAT

Education

Ph.D. in organic chemistry

MS in Organic Chemistry

Tools

Modeling & simulation tools

Data analytics

Job description

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life‑changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us. The Synthetic Molecule Design and Development (SMDD) team is involved in key activities for the development of synthetic active pharmaceutical ingredients (API) from pre‑clinical phases through commercialization of drug substances and drug products. Our chemists, engineers, and scientists develop key technical and business solutions across the portfolio using their deep technical expertise to accelerate testing of the clinical hypothesis and overall drug development.

Position Summary

Our team is looking for experienced and creative individuals to lead synthetic molecule route development as well as unit operation definition of drug candidates to support preclinical studies through Phase 2 enabling studies and regulatory submissions. The position presents an opportunity to lead dynamic teams comprised of process chemists, analytical chemists, material scientists, and engineers. Additionally, candidates will provide oversight for external R&D, tech transfer, and campaign execution.

Responsibilities

• 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
• Design experimental laboratory plans in support of route and process design, definition, optimization, and technology transfer objectives
• Exhibit a high learning agility with the ability to understand and exploit new scientific concepts and methods across multiple fields; be able to apply these takeaways to a portfolio of small molecule candidates.
• Possess solid understanding in unit operation design 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, manufacturing technologies, and practices to deliver an exciting portfolio
• Collaborate in technology transfer activities to CRO/CMO organizations and internal Lilly manufacturing nodes to ensure processes are technically robust, well developed and characterized, and safe
• Ability to integrate process (and property design) data based on a fundamental understanding of the underlying physical processes
• 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
• 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 and encourage others to share knowledge on challenging technical issues.
• Actively collaborate and exhibit influence in the external scientific environment and demonstrate an ability to recognize and integrate external innovation across the Lilly synthetic portfolio

Minimum Qualifications

• Ph.D. in organic chemistry, or a related field with 8+ years of pharmaceutical process development experience OR MS in Organic Chemistry or related field with 15+ years' experience.

Additional Skills/Preferences

Experience within the pharmaceutical sector is preferred; however, other experience may meet expectations. Prior experience in active ingredient development and associated formulated product is acceptable. Experience with developing chemical processes for pre‑clinical to Phase 3 enabling small molecule projects. 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 Knowledge and experience with management of a technical project and ability to build ideas for future work plans Experience with modern analytical techniques and process analytical technologies (PAT) 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. Experience with modeling and simulation tools, data analytics, and predictive analytics Ability to transform ideas into marketable products and processes Demonstrated leadership capabilities, good communication skills and a sustained tendency for collaboration Ability to prioritize multiple activities and handle ambiguity Ability to influence others to promote a positive work environment.

Additional Information

Potential exposure to chemicals, allergens, and loud noises. Travel: 0 to 10% Position Location: Indianapolis, IN; Lilly Technology Center‑North (LTC‑N)

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees.

• Africa
• Middle East
• Central Asia (AMECA)
• Black Employees at Lilly (BE@Lilly)
• Chinese Culture Network (CCN)
• EnAble
• Evolve
• Lilly Indian Network (LIN)
• Organization of Latinx at Lilly (OLA)
• Pride (LGBTQ+ Allies)
• Veterans Leadership Network (VLN)
• Women’s Initiative for Leading at Lilly (WILL)

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $153,000 - $264,000 Full‑time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).

• including eligibility to participate in a company-sponsored 401(k)
• pension
• vacation benefits
• eligibility for medical, dental, vision and prescription drug benefits
• flexible benefits (e.g., 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 (e.g., employee assistance program, fitness benefits, and employee clubs and activities)

We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe!