Director Late 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 benefits

Flexible benefits

Life insurance

Leave benefits

Well-being programs

Job summary

Eli Lilly and Company in Indianapolis, IN seeks an experienced leader to guide late-phase synthetic molecule process development. You will finalize commercial routes, define control strategies for Phase 3 supply, and oversee tech transfer and regulatory submissions.

Lead cross-disciplinary teams across chemistry, analytics, materials science and engineering, while applying QbD, DoE, and AI/ML to accelerate development and ensure scalable, robust manufacturing.

Qualifications

• PhD in organic chemistry or related field with 8+ years pharma process development.
• MS in Organic Chemistry or related field with 15+ years experience.
• Experience with developing chemical processes for Phase 3 through commercialization.

Responsibilities

• Lead finalization of commercial synthetic routes and robust API manufacturing processes.
• Design experimental plans to support route design, optimization, and tech transfer objectives.
• Apply risk-based characterization and control strategy development for process validation.
• Lead cross-disciplinary teams to refine routes and manufacturing technologies.
• Collaborate on technology transfer to CRO/CMO and internal Lilly nodes.
• Leverage AI/ML to inform design space, impurity fate, scale-up, and regulatory justification.
• Author regulatory submissions and respond to regulatory questions.

Skills

Process development

CMC expertise

Tech transfer

DoE

QbD

AI/ML

Regulatory submissions

Project leadership

Education

PhD in Organic Chemistry

MS in Organic Chemistry

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.

Position Summary

Our team is looking for experienced and creative individuals to lead late-phase synthetic molecule process development. This includes finalizing the commercial route and process, characterizing the process, and defining the control strategy to support Phase 3 clinical supply, registration stability, regulatory submissions, process validation, and commercial hand-off. 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 in the utilization of modern synthetic organic and process chemistry techniques to address key CMC challenges
• Lead and/or supervise the finalization of commercial synthetic routes and the development of robust, scalable, and well-characterized API manufacturing processes, including starting materials selection and justification of the commercial route
• 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 dynamic portfolio of small molecule programs
• Possess solid understanding in unit operation design and scale-up methodologies; build and apply groundbreaking technology and novel platforms within a time constrained environment
• Apply risk-based process characterization, design space definition, and control strategy development to ensure readiness for process validation and commercial manufacture
• Leverage predictive modeling, simulation, and machine learning to inform design space definition, impurity fate and purge, scale-up, and control strategy, reducing experimental burden and strengthening regulatory justification
• Lead a cross-disciplinary team to refine manufacturing routes and manufacturing technologies to advance an exciting small molecule portfolio
• Deliver commercial-ready manufacturing processes, including impurity control, process robustness, and lifecycle strategy, and enable effective handoff to internal and external commercial manufacturing sites
• 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
• Integrate process and property data with a fundamental understanding of the underlying physical processes; build and apply mechanistic, kinetic, and data-driven models to predict process performance and guide development decisions
• Utilize modern artificial intelligence and machine learning tools to accelerate development and deepen process understanding
• 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 Phase 3 through commercialization of 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).
• Experience applying Quality by Design (QbD) principles, design of experiments (DoE), and risk assessments to establish process understanding, proven acceptable ranges, and design space.
• 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, predictive analytics, and AI/ML.
• 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.

If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Potential exposure to chemicals, allergens, and loud noises.

Travel: 0 to 20%

Position Location: Indianapolis, IN; Lilly Technology Center-North (LTC-N)

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. Our current groups include: 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) and 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).

Benefits

• 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)

Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

#WeAreLilly At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people. We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe!