Crystallization Process Development Engineer – Drug Substance SMDD

Lilly • Indianapolis, IN

9d • $129,000 - $209,000 • Onsite

About The Position

Lilly’s Synthetic Molecule Design and Development (SMDD) is involved in key activities for the development of active pharmaceutical ingredients and formulated drug products from pre-clinical phases through commercialization of drug substances and drug products for small molecules, synthetic oligonucleotides, and synthetic peptides. Our scientists develop key technical and business solutions across the portfolio using their deep technical expertise to speed up testing of clinical hypothesis and overall drug development. SMDD tackles this diversity of responsibilities by recognizing that an even greater diversity of talents and cultures is vital to deliver the next generation of life changing medicines to patients.

Crystallization is where chemistry becomes medicine — the step that determines whether a promising molecule can be reliably purified, formulated, and manufactured at scale. We're looking for an outstanding crystallization engineer to join our Crystallization Science team and take ownership of that critical transformation across an exciting and diverse pipeline of small molecules, oligonucleotides, and synthetic peptides.
You'll work in a brand-new, pioneering development facility in Indianapolis, embedded in a highly collaborative environment alongside synthetic chemists, analytical scientists, formulation experts, and process engineers — with the resources and cross-functional support to solve genuinely hard problems, not just implement someone else's protocol.

Requirements

• PhD in Chemical Engineering
• MSc in Chemical Engineering +7 years of experience
• BSc in Chemical Engineering +10 years of experience
• Hands-on experience designing, developing, and optimizing crystallization processes for pharmaceutical APIs — including polymorph screening, solid-form selection, and particle engineering.
• Fluency with crystallization modeling and simulation tools (population balance modeling, thermodynamic solubility modeling), plus a data-driven approach to DoE and process analytics.
• Work across both batch and continuous unit operations, with a solid grasp of the technical considerations behind equipment design, process monitoring, and PAT system integration.
• A natural communicator — someone who can distill complex technical work into clear documentation and compelling presentations for audiences ranging from bench scientists to regulatory reviewers.
• A track record of thriving in multidisciplinary teams, where influence comes from expertise and collaboration rather than title alone.
• Leadership instincts: someone who leans into challenges, proactively clears roadblocks, and can lead through ambiguity even without formal authority.
• A collaborative, team-first attitude paired with strong interpersonal skills.
• Sharp problem-solving instincts, close attention to detail, and a results-driven approach — even when the pace picks up.

Nice To Haves

• solid understanding of cGMP and ICH guidelines (Q6A, Q8, Q11)

Responsibilities

• Lead crystallization process design end-to-end — from first-principles science (nucleation kinetics, crystal growth, supersaturation control, solubility thermodynamics, heat/mass transfer) through robust, scalable processes that deliver clinical trial materials on time and on spec.
• Innovate across a full toolkit of crystallization strategies — cooling, antisolvent, reactive, and seeded crystallization — paired with modern PAT tools (in-situ imaging, FBRM, ATR-FTIR, Raman) and QbD/DoE methodologies to build deep process understanding and real control, not just documentation.
• Be the go-to crystallization expert on integrated drug substance project teams, driving particle engineering strategy (size distribution, morphology, polymorphic form, impurity rejection) and directly influencing regulatory filings (IND, IMPD, NDA) through your own authored content.
• Bridge bench to plant to patient — partner with formulation, analytical, and manufacturing teams to ensure the APIs you develop translate into drug products that actually work, and lead scale-up and technology transfer to pilot plants and external CMOs.
• Grow as a scientific leader — mentor emerging talent, publish and present in venues like AIChE and ACS, and help shape standards and control strategies across the broader organization.
• Stay at the leading edge — engage with academic partners, pre-competitive consortia, and the latest advances in continuous crystallization and particle engineering as part of a culture that values external scientific contribution.

Benefits

• company bonus (depending, in part, on company and individual performance)
• company-sponsored 401(k)
• pension
• vacation benefits
• 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)

What This Job Offers

• Job Type: Full-time
• Career Level: Senior