Director, Analytical Chemistry - Peptides
Eli Lilly and Company
August 24, 2026
On-site
Indianapolis, IN
Operations
Position Responsibilities:
- Lead analytical efforts for peptide drug substance and/or drug product development and commercialization; apply regulatory requirements and industry trends.
- Develop analytical methods; justify specifications; design stability studies; author regulatory submissions; respond to global regulatory agency questions.
- Implement technical solutions/analytical strategies for peptide formulation and drug product process design; deliver robust control strategies.
- Author IND/CTA, BLA/NDA/MAA, and country-specific Response to Questions (RtQ).
- Provide technical guidance to external CRO/CMO networks; execute technology transfer to CRO/CMO and Lilly manufacturing sites.
- Introduce new methodologies for modality optimization and/or new control strategies.
- Plan/manage short- and long-term development; manage technical agendas/timelines; recommend resources; communicate progress and changes.
- Collaborate across Discovery, Development, and Manufacturing to support clinical trials and regulatory submissions.
- Mentor scientific staff; drive innovation; demonstrate strong communication and leadership.
Basic Qualifications:
- Ph.D. in analytical/bioanalytical chemistry (or related) with 5+ years pharma experience; OR B.S. (15+ years) OR M.S. (10+ years).
- Experience developing analytical and control strategies for peptide drug substance and/or drug products.
- Experience with analytical method technical transfer into manufacturing.
- Experience developing global regulatory strategies; authoring submissions; responding to regulatory questions; registering products globally.
Additional Skills/Preferences:
- Strong technical skills, creativity, technical project management.
- Leadership, adaptability/change drive, persuasion/influence/negotiation.
- Collaboration, prioritization, ambiguity management, ability to influence for a positive environment.
Benefits (eligibility): company bonus; 401(k)/pension; vacation; medical/dental/vision/prescription; flexible benefits; life and death benefits; certain time off/leave; well-being benefits (EAP, fitness, clubs).
Travel/Location: 0–15%; Indianapolis, IN (Lilly Technology Center–North).
Application instructions: If you need an accommodation to submit a resume, complete the workplace accommodation request form: https://careers.lilly.com/us/en/workplace-accommodation
- Lead analytical efforts for peptide drug substance and/or drug product development and commercialization; apply regulatory requirements and industry trends.
- Develop analytical methods; justify specifications; design stability studies; author regulatory submissions; respond to global regulatory agency questions.
- Implement technical solutions/analytical strategies for peptide formulation and drug product process design; deliver robust control strategies.
- Author IND/CTA, BLA/NDA/MAA, and country-specific Response to Questions (RtQ).
- Provide technical guidance to external CRO/CMO networks; execute technology transfer to CRO/CMO and Lilly manufacturing sites.
- Introduce new methodologies for modality optimization and/or new control strategies.
- Plan/manage short- and long-term development; manage technical agendas/timelines; recommend resources; communicate progress and changes.
- Collaborate across Discovery, Development, and Manufacturing to support clinical trials and regulatory submissions.
- Mentor scientific staff; drive innovation; demonstrate strong communication and leadership.
Basic Qualifications:
- Ph.D. in analytical/bioanalytical chemistry (or related) with 5+ years pharma experience; OR B.S. (15+ years) OR M.S. (10+ years).
- Experience developing analytical and control strategies for peptide drug substance and/or drug products.
- Experience with analytical method technical transfer into manufacturing.
- Experience developing global regulatory strategies; authoring submissions; responding to regulatory questions; registering products globally.
Additional Skills/Preferences:
- Strong technical skills, creativity, technical project management.
- Leadership, adaptability/change drive, persuasion/influence/negotiation.
- Collaboration, prioritization, ambiguity management, ability to influence for a positive environment.
Benefits (eligibility): company bonus; 401(k)/pension; vacation; medical/dental/vision/prescription; flexible benefits; life and death benefits; certain time off/leave; well-being benefits (EAP, fitness, clubs).
Travel/Location: 0–15%; Indianapolis, IN (Lilly Technology Center–North).
Application instructions: If you need an accommodation to submit a resume, complete the workplace accommodation request form: https://careers.lilly.com/us/en/workplace-accommodation