Director - BRD Analytical Development
Eli Lilly and Company
2 days ago
On-site
Indianapolis, IN
Operations
Responsibilities:
- Lead analytical efforts for pharmaceutical drug substance and/or drug product development and commercialization; ensure methods are technically sound, well-developed, and fit-for-purpose.
- Develop analytical methods, justify specifications, design stability studies, and author regulatory submissions; address questions from global regulators.
- Implement technical solutions/analytical strategies to enable process design; collaborate to deliver robust control strategies.
- Author IND/CTA and BLA/NDA/MAA, including country-specific Response to Questions (RtQ).
- Provide technical guidance to external CRO/CMO network; execute technology transfer to CRO/CMO and Lilly manufacturing.
- Apply scientific concepts across peptide, oligonucleotide, mAb, gene therapy, and/or bioconjugate modalities; introduce new methodologies/control strategies for new/existing modalities.
- Plan/manage short- and long-term development activities; manage timelines/agenda, resource allocation, and progress updates.
- Mentor/develop scientific staff; collaborate across Discovery/Development/Manufacturing for clinical/regulatory deliverables.
Qualifications (Required):
- PhD in Analytical Chemistry/Bioanalytical Chemistry (5+ years in pharma) OR BS Chemistry (15+ years) OR MS Chemistry (10+ years).
- Experience leading drug substance/drug product analytics and familiarity with regulatory requirements/trends.
- Global regulatory strategy experience; authored IND/CTA, BLA/NDA/MAA, and RtQ.
- Technical project management and external-network guidance; technology transfer experience.
Preferences:
- Strong innovation/business value; creativity; persuasion/influence/negotiation; collaboration; prioritization in ambiguity.
Benefits:
- 401(k), pension, vacation; medical/dental/vision/prescription; flexible benefits; life insurance; time off/leave; well-being benefits.
Additional info:
- Travel: 0–15%; onsite in Indianapolis, IN (LTC-N).
- Lead analytical efforts for pharmaceutical drug substance and/or drug product development and commercialization; ensure methods are technically sound, well-developed, and fit-for-purpose.
- Develop analytical methods, justify specifications, design stability studies, and author regulatory submissions; address questions from global regulators.
- Implement technical solutions/analytical strategies to enable process design; collaborate to deliver robust control strategies.
- Author IND/CTA and BLA/NDA/MAA, including country-specific Response to Questions (RtQ).
- Provide technical guidance to external CRO/CMO network; execute technology transfer to CRO/CMO and Lilly manufacturing.
- Apply scientific concepts across peptide, oligonucleotide, mAb, gene therapy, and/or bioconjugate modalities; introduce new methodologies/control strategies for new/existing modalities.
- Plan/manage short- and long-term development activities; manage timelines/agenda, resource allocation, and progress updates.
- Mentor/develop scientific staff; collaborate across Discovery/Development/Manufacturing for clinical/regulatory deliverables.
Qualifications (Required):
- PhD in Analytical Chemistry/Bioanalytical Chemistry (5+ years in pharma) OR BS Chemistry (15+ years) OR MS Chemistry (10+ years).
- Experience leading drug substance/drug product analytics and familiarity with regulatory requirements/trends.
- Global regulatory strategy experience; authored IND/CTA, BLA/NDA/MAA, and RtQ.
- Technical project management and external-network guidance; technology transfer experience.
Preferences:
- Strong innovation/business value; creativity; persuasion/influence/negotiation; collaboration; prioritization in ambiguity.
Benefits:
- 401(k), pension, vacation; medical/dental/vision/prescription; flexible benefits; life insurance; time off/leave; well-being benefits.
Additional info:
- Travel: 0–15%; onsite in Indianapolis, IN (LTC-N).