Director - Analytical Chemistry
Eli Lilly and Company
August 23, 2026
On-site
Indianapolis, IN
$148,500 - $257,400 USD yearly
Operations
Position Responsibilities:
- Lead hands-on analytical work for commercial development of drug substance and/or drug product processes.
- Develop analytical methods, justify specifications, design stability studies, establish starting material rationales, identify impurities, and test drug product performance (e.g., dissolution/disintegration).
- Implement analytical strategies to support drug substance process and drug product formulation development.
- Collaborate to deliver robust control strategies for drug substances, drug products, and/or intermediates (e.g., spray-dried dispersions).
- Author IND/CTA, NDA/MAA, and country-specific responses; support product registrations globally.
- Provide technical guidance to external network; ensure methods are fit for purpose; execute tech transfer to CRO/CMOs and Lilly manufacturing.
- Demonstrate learning agility across domains (chemistry, pharma sciences, PAT, modeling/simulation).
- Directly manage 2–4 analytical scientists; mentor, develop, and provide day-to-day technical guidance.
- Plan/manage short- and long-term development activities, timelines, and resourcing; communicate progress and propose changes.
- Engage externally to recognize and apply innovation across the synthetic portfolio.
Basic Qualifications:
- Ph.D. in analytical or bioanalytical chemistry (or related) and >8 years pharma industry experience.
- Technical leadership experience in innovator pharma product development/commercialization focused on small molecules, synthetic peptides, oligonucleotides, and/or ADC payload-linker elements.
- Familiarity with regulatory requirements and emerging industry trends.
Additional Skills/Preferences:
- Strong technical skills creating business value.
- Creativity to translate ideas into marketable products/processes.
- Ability to drive/accept change; influence/persuade/negotiation.
- Prioritize multiple activities; manage ambiguity.
Additional Information:
- Travel: 0–10%.
- Location: On-site, Indianapolis, IN; Lilly Technology Center-North (LTC-N).
- Lead hands-on analytical work for commercial development of drug substance and/or drug product processes.
- Develop analytical methods, justify specifications, design stability studies, establish starting material rationales, identify impurities, and test drug product performance (e.g., dissolution/disintegration).
- Implement analytical strategies to support drug substance process and drug product formulation development.
- Collaborate to deliver robust control strategies for drug substances, drug products, and/or intermediates (e.g., spray-dried dispersions).
- Author IND/CTA, NDA/MAA, and country-specific responses; support product registrations globally.
- Provide technical guidance to external network; ensure methods are fit for purpose; execute tech transfer to CRO/CMOs and Lilly manufacturing.
- Demonstrate learning agility across domains (chemistry, pharma sciences, PAT, modeling/simulation).
- Directly manage 2–4 analytical scientists; mentor, develop, and provide day-to-day technical guidance.
- Plan/manage short- and long-term development activities, timelines, and resourcing; communicate progress and propose changes.
- Engage externally to recognize and apply innovation across the synthetic portfolio.
Basic Qualifications:
- Ph.D. in analytical or bioanalytical chemistry (or related) and >8 years pharma industry experience.
- Technical leadership experience in innovator pharma product development/commercialization focused on small molecules, synthetic peptides, oligonucleotides, and/or ADC payload-linker elements.
- Familiarity with regulatory requirements and emerging industry trends.
Additional Skills/Preferences:
- Strong technical skills creating business value.
- Creativity to translate ideas into marketable products/processes.
- Ability to drive/accept change; influence/persuade/negotiation.
- Prioritize multiple activities; manage ambiguity.
Additional Information:
- Travel: 0–10%.
- Location: On-site, Indianapolis, IN; Lilly Technology Center-North (LTC-N).