Director - BRD Analytical Development
Eli Lilly and Company
August 23, 2026
On-site
Indianapolis, IN
Operations
Responsibilities:
- Lead analytical efforts for pharmaceutical drug substance and/or drug product development and commercialization; stay current on regulatory requirements and industry trends.
- Develop analytical methods, justify specifications, design stability studies, author regulatory submissions, and address questions from global regulatory agencies.
- Implement analytical strategies to support drug substance/drug product process design; collaborate to deliver robust control strategies.
- Author IND/CTA, BLA/NDA/MAA, and country-specific Response to Questions (RtQ).
- Provide technical guidance for analytical work in the external network; ensure methods are technically sound, well developed, and fit-for-purpose; execute technology transfer to CRO/CMO and Lilly sites.
- Apply scientific concepts across peptide, oligonucleotide, monoclonal antibody, gene therapy, and/or bioconjugate modalities; introduce new methodologies.
- Plan/manage short- and long-term development activities; set technical agendas/timelines; recommend resources and communicate progress.
- Collaborate across Discovery, Development, and Manufacturing to deliver materials/information for clinical trials and regulatory submissions.
- Mentor and develop scientific staff; communicate with strong oral/written and leadership skills.
Qualifications (Basic Requirements):
- Ph.D. in Analytical or Bioanalytical Chemistry (5+ years pharma industry) OR B.S. (15+ years) OR M.S. (10+ years).
- Experience leading analytical efforts for drug substance/drug product development and commercialization; introduced new methodologies.
- Experience with global regulatory strategy and submissions; authored IND/CTA, BLA/NDA/MAA, and RtQ.
- Experience managing technical projects and technology transfer.
- Demonstrated communication, leadership, change leadership, and staff development.
Additional Preferences:
- Innovation/business-value mindset; creativity; persuasion/influence/negotiation; collaboration; prioritization under ambiguity; influence for a positive environment; technical proficiency for future plans.
Additional Information:
- Travel: 0–15%; onsite Indianapolis, IN (LTC-N). Potential exposure to chemicals/allergens and loud noises; lab environment.
- Anticipated wage: $139,500–$217,800; bonus eligibility; comprehensive benefits incl. 401(k), pension, medical/dental/vision, life insurance, PTO/leave, and well-being benefits (eligibility-dependent).
- Lead analytical efforts for pharmaceutical drug substance and/or drug product development and commercialization; stay current on regulatory requirements and industry trends.
- Develop analytical methods, justify specifications, design stability studies, author regulatory submissions, and address questions from global regulatory agencies.
- Implement analytical strategies to support drug substance/drug product process design; collaborate to deliver robust control strategies.
- Author IND/CTA, BLA/NDA/MAA, and country-specific Response to Questions (RtQ).
- Provide technical guidance for analytical work in the external network; ensure methods are technically sound, well developed, and fit-for-purpose; execute technology transfer to CRO/CMO and Lilly sites.
- Apply scientific concepts across peptide, oligonucleotide, monoclonal antibody, gene therapy, and/or bioconjugate modalities; introduce new methodologies.
- Plan/manage short- and long-term development activities; set technical agendas/timelines; recommend resources and communicate progress.
- Collaborate across Discovery, Development, and Manufacturing to deliver materials/information for clinical trials and regulatory submissions.
- Mentor and develop scientific staff; communicate with strong oral/written and leadership skills.
Qualifications (Basic Requirements):
- Ph.D. in Analytical or Bioanalytical Chemistry (5+ years pharma industry) OR B.S. (15+ years) OR M.S. (10+ years).
- Experience leading analytical efforts for drug substance/drug product development and commercialization; introduced new methodologies.
- Experience with global regulatory strategy and submissions; authored IND/CTA, BLA/NDA/MAA, and RtQ.
- Experience managing technical projects and technology transfer.
- Demonstrated communication, leadership, change leadership, and staff development.
Additional Preferences:
- Innovation/business-value mindset; creativity; persuasion/influence/negotiation; collaboration; prioritization under ambiguity; influence for a positive environment; technical proficiency for future plans.
Additional Information:
- Travel: 0–15%; onsite Indianapolis, IN (LTC-N). Potential exposure to chemicals/allergens and loud noises; lab environment.
- Anticipated wage: $139,500–$217,800; bonus eligibility; comprehensive benefits incl. 401(k), pension, medical/dental/vision, life insurance, PTO/leave, and well-being benefits (eligibility-dependent).