Sr. Director, Process Chemistry

Eli Lilly and Company; Indianapolis (IN); On-site; USD 148,500 - 257,400; Full time

Benefits offered by this job

Comprehensive benefit program

Company-sponsored 401(k)

Pension benefits

Flexible benefits

Job summary

A leading pharmaceutical company in Indianapolis seeks an experienced candidate to lead synthetic molecule route commercialization and process optimization efforts. The role demands expertise in modern chemistry practices, regulatory knowledge, and leadership skills. Candidates should hold a Ph.D. or MS in organic chemistry with significant experience in pharmaceutical process development, regulatory submissions, and collaboration across teams. The position offers competitive compensation and comprehensive benefits including a company bonus, 401(k), and various health benefits.

Qualifications

• Ph.D. or MS in a related field with extensive experience in pharmaceutical process development.
• Experience in active ingredient development and regulatory submissions.
• Demonstrated leadership and collaboration skills.

Responsibilities

• Lead synthetic molecule route commercialization and process optimization.
• Supervise the design and development of new synthetic routes.
• Collaborate with internal and external teams for technology transfer.

Skills

Modern synthetic organic chemistry

Process chemistry techniques

Leadership abilities

Analytical problem-solving

Regulatory knowledge

Education

Ph.D. in organic chemistry

MS in Organic Chemistry

Tools

Process analytical technologies (PAT)

Modeling and simulation tools

Job description

Position Summary

Our team is looking for experienced and creative individuals to lead synthetic molecule route commercialization as well as process optimization and unit operation definition of drug candidates to support clinical trials, product commercialization, and regulatory submissions. The position presents an opportunity to lead dynamic teams comprised of process chemists, analytical chemists, formulation 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
• 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, oligonucleotide, and synthetic peptide, and other emerging synthetic modalities
• Possess solid understanding in unit operation design, process modeling, process equipment selection, 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
• Provide technical leadership in the scale‑up and demonstration of new chemical processes in development and commercial scale equipment; 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
• Design experimental laboratory plans in support of route and process design, definition, optimization, and technology transfer objectives.
• Ability to integrate process (and property design) data based on a fundamental understanding of the underlying physical processes
• Apply advancements in technology (PAT) and modeling platforms to understand and lead experimental protocols. 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.
• 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.
• Possess deep understanding of the external global regulatory climate and emerging requirements; ability to address key CMC regulatory questions that enable clinical studies and support marketing authorization applications
• 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 demonstrates 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 10+ 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. Relevant industrial sectors would include agrochemicals, nutraceuticals, specialty chemicals, and personal care products. Experience with developing chemical processes from mid‑development cycle (proof of concept) to product commercialization.
• 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 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)

Compensation and Benefits

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $148,500 - $257,400.

Full‑time employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, 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; and 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.

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.