Director Engineering - Synthetic Molecule Design and Development

Eli Lilly and Company • Us, IN

4d • Onsite

About The Position

Lilly’s Synthetic Molecule Design and Development (SMDD) organization supports the development of synthetic active pharmaceutical ingredients from preclinical development through commercialization of drug substances and drug products. The Director Engineering will lead unit-operation development and process optimization for synthetic drug candidates supporting clinical trials, regulatory submissions, and product commercialization. The role leads multidisciplinary teams that may include process chemists, analytical chemists, formulation scientists, and engineers, and applies technical expertise to a portfolio that includes small molecules, oligonucleotides, and synthetic peptides.

The Director provides technical leadership for process design, development, modeling, equipment selection, scale-up, and technology transfer. The role works with internal and external manufacturing partners and cross-functional colleagues to deliver robust, safe, well-characterized processes and the materials and information needed for clinical trials and regulatory submissions. It also manages development plans, resources, timelines, and project progress; mentors and develops scientific staff; and applies external scientific and regulatory developments to Lilly’s synthetic portfolio.

The position is based at Lilly Technology Center-North in Indianapolis, Indiana. Travel is listed as 0–10%. The anticipated salary range is $156,000–$275,000, and eligible full-time employees may receive a company bonus and participate in a comprehensive benefits program.

Requirements

• Ph.D. in chemical engineering or a closely related field and 8 or more years of experience, or a master's degree and 15 or more years of experience.
• Experience developing chemical processes from mid-development (proof of concept) through product commercialization.
• Experience transferring processes into manufacturing operations.
• Fluent knowledge of unit-operation design, process modeling, process equipment selection, and scale-up methodologies.
• Working knowledge of modern synthetic organic chemistry.
• Ability to learn and apply scientific concepts and methods across multiple disciplines and modalities.
• Strong oral and written communication, organizational, and leadership skills.
• Ability to manage ambiguity, prioritize multiple activities, and plan and manage technical development work.
• Ability to collaborate across disciplines and with internal and external partners.
• Ability to guide, mentor, and develop scientific staff.
• Experience in an industrial sector relevant to process development; prior pharmaceutical-sector experience is desired, while relevant experience in other sectors may qualify.
• Experience developing an active ingredient and associated formulated product is acceptable.

Nice To Haves

• Experience authoring regulatory submissions and responding to regulatory questions.
• Experience with modeling and simulation tools, data analytics, and predictive analytics.
• Experience with online and offline analytical techniques and process analytical technologies (PAT).
• Strong technical skills that generate business value.
• Creativity and ability to transform ideas into marketable products and processes.
• Experience managing technical projects.
• Demonstrated leadership, particularly in a team environment.
• Demonstrated ability to drive and accept change.
• Success in persuasion, influence, and negotiation.
• Strong interpersonal skills and a sustained tendency toward collaboration.
• Ability to influence others and promote a positive work environment.
• Understanding of the external scientific and regulatory landscape.
• Demonstrated initiative and risk-taking.
• Technical proficiency and ability to create ideas for future work plans.
• Established external publication record.

Responsibilities

• Lead or supervise the design and development of synthetic routes for manufacturing active pharmaceutical ingredients using technologies such as continuous processing, automated reaction screening, process analytical technology (PAT), and modeling and simulation.
• Lead cross-disciplinary teams evaluating and refining manufacturing routes, technologies, and practices across a challenging portfolio.
• Provide technical guidance on scaling up and demonstrating chemical processes using development- and commercial-scale equipment.
• Participate in technology transfer to CRO/CMO organizations and Lilly manufacturing, ensuring processes are technically sound, well developed, characterized, and safe.
• Design laboratory experiments to support process design, definition, optimization, and technology transfer.
• Generate process and property-design data based on fundamental understanding of underlying physical processes, and use PAT and modeling platforms to guide experimental protocols.
• Plan and manage short- and long-term development activities; develop or review technical agendas and timelines; recommend resource allocation; communicate progress; and propose changes to timelines, objectives, or direction.
• Collaborate with internal and external manufacturing partners to develop robust chemical processes suitable for efficient drug-substance manufacturing.
• Collaborate with Product Delivery, Project Management, Quality, Manufacturing, and Regulatory colleagues to deliver material and information for clinical trials and regulatory submissions.
• Supervise, mentor, and develop scientific staff, supporting their technical and professional growth, excellence, and knowledge sharing.
• Engage with the external environment and recognize and apply external innovation across Lilly’s synthetic portfolio.
• Address CMC regulatory questions that enable clinical studies and support marketing authorization applications.
• Apply unit-operation design, process modeling, equipment selection, and scale-up expertise to challenge existing methods and develop new technologies and platforms.
• Foster initiative, accountability, knowledge sharing, collaboration, and inclusive contributions from team members.

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.
• 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