Crystallization Process Development Engineer – Drug Substance SMDD

Initial Therapeutics, Inc.; Indianapolis (IN); On-site; USD 129,000 - 209,000; Full time

Benefits offered by this job

401(k) plan

Pension

Vacation benefits

Flexible benefits

Job summary

Lilly in Indianapolis is seeking a crystallization engineer to own end‑to‑end crystallization process design for diverse pipelines. You will apply first‑principles science with robust, scalable methods to deliver clinically relevant materials for small molecules, oligonucleotides, and peptides.

You will lead innovation across crystallization strategies, utilize PAT tools, and contribute to regulatory filings.

Qualifications

• PhD in Chemical Engineering is required.
• MSc in Chemical Engineering with 7+ years of experience or
• BSc in Chemical Engineering with 10+ years of experience.

Responsibilities

• Lead crystallization process design end-to-end for clinical materials.
• Develop and implement a full toolkit of crystallization strategies with PAT.
• Serve as crystallization expert on cross-functional teams and support regulatory filings.
• Partner with formulation, analytical, and manufacturing teams for scale‑up and tech transfer.
• Mentor junior staff and contribute to internal standards and DoE culture.

Skills

Crystallization design

Scale-up

PAT tools

DoE methods

Leadership

Education

PhD in Chemical Engineering

MSc in Chemical Engineering

BSc in Chemical Engineering

Tools

Population balance modeling

Thermodynamic solubility modeling

Process 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.

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.

Shape How Tomorrow's Medicines Take Shape

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.

What We're Looking For

An engineer with strong technical depth in crystallization science and engineering, a track record (or clear potential) for scientific leadership, solid understanding of cGMP and ICH guidelines (Q6A, Q8, Q11), and — just as important — a genuine passion for collaborative, team-based problem solving in a diverse and inclusive environment.

What You'll Do

• 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.

Minimum Qualifications

• PhD in Chemical Engineering
• MSc in Chemical Engineering +7 years of experience
• BSc in Chemical Engineering +10 years of experience

Additional Skills and Preferences

• 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 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.

Additional Information

• Travel: 0 to 10%
• Position Location: Indianapolis, IN LTC‑N, onsite work 5 days/week.

Please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance.

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

$129,000 - $209,000

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
• 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.

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