Director - Dissolution Science & Biopharmaceutics
Eli Lilly and Company
August 23, 2026
On-site
Indianapolis, IN
Operations
Responsibilities:
- Develop, validate, and justify phase-appropriate dissolution methods linking in vitro performance to in vivo behavior for immediate- and modified-release oral solid dosage forms.
- Build and execute biopharmaceutics strategies using in vitro/in vivo/in silico tools, including PBBM, to assess oral absorption, predict bridging risk, and establish clinically relevant specifications.
- Author and defend dissolution/biopharmaceutics content in IND/CTAs, NDA/MAAs, and responses to health authority questions (biowaiver justifications; IVIVC/IVIVR dossiers).
- Partner cross-functionally to define product performance control strategies (specifications, dissolution lifecycle management, post-approval change strategies).
- Plan and lead dissolution/biopharmaceutics development activities; set technical agendas/timelines and resource recommendations.
- Lead 1–5 scientists (mentorship, career development, performance coaching).
- Engage externally via publications, conferences, collaborations; integrate emerging science (e.g., PAT, modeling/simulation) into practice.
Qualifications:
- Ph.D. (8+ years industry) OR M.S. (12+ years) OR B.S. (15+ years) in Pharmaceutical Sciences, Analytical/Physical Chemistry, Chemical Engineering, or related.
- Demonstrated leadership in dissolution science/biopharmaceutics and product performance for small molecules; ownership from early development through regulatory submission.
- Track record authoring CMC/biopharmaceutics regulatory sections and responding to health authority questions.
- Experience with PBBM for biowaivers/bridging/specification setting; knowledge of FDA/EMA and regulatory trends.
Preferred/Additional Skills:
- Strong publication record and external engagement.
- Proficiency with biopharmaceutics modeling platforms (e.g., GastroPlus, Simcyp, DDDPlus, STELLA); IVIVC/IVIVR or bioequivalence “safe space” experience.
- Formulation/physical pharmacy knowledge (e.g., poorly soluble compounds; amorphous solid dispersions, spray-dried intermediates).
- Ability to influence cross-functional technical decisions; mentor scientists.
Additional Information:
- Travel: 0–10%.
- Location: On-site, Indianapolis, IN; Lilly Technology Center-North (LTC-N).
- Anticipated wage: $148,500–$257,400; may be eligible for company bonus and a comprehensive benefits program (e.g., 401(k), medical/dental/vision, life insurance, time off, well-being benefits).
- Develop, validate, and justify phase-appropriate dissolution methods linking in vitro performance to in vivo behavior for immediate- and modified-release oral solid dosage forms.
- Build and execute biopharmaceutics strategies using in vitro/in vivo/in silico tools, including PBBM, to assess oral absorption, predict bridging risk, and establish clinically relevant specifications.
- Author and defend dissolution/biopharmaceutics content in IND/CTAs, NDA/MAAs, and responses to health authority questions (biowaiver justifications; IVIVC/IVIVR dossiers).
- Partner cross-functionally to define product performance control strategies (specifications, dissolution lifecycle management, post-approval change strategies).
- Plan and lead dissolution/biopharmaceutics development activities; set technical agendas/timelines and resource recommendations.
- Lead 1–5 scientists (mentorship, career development, performance coaching).
- Engage externally via publications, conferences, collaborations; integrate emerging science (e.g., PAT, modeling/simulation) into practice.
Qualifications:
- Ph.D. (8+ years industry) OR M.S. (12+ years) OR B.S. (15+ years) in Pharmaceutical Sciences, Analytical/Physical Chemistry, Chemical Engineering, or related.
- Demonstrated leadership in dissolution science/biopharmaceutics and product performance for small molecules; ownership from early development through regulatory submission.
- Track record authoring CMC/biopharmaceutics regulatory sections and responding to health authority questions.
- Experience with PBBM for biowaivers/bridging/specification setting; knowledge of FDA/EMA and regulatory trends.
Preferred/Additional Skills:
- Strong publication record and external engagement.
- Proficiency with biopharmaceutics modeling platforms (e.g., GastroPlus, Simcyp, DDDPlus, STELLA); IVIVC/IVIVR or bioequivalence “safe space” experience.
- Formulation/physical pharmacy knowledge (e.g., poorly soluble compounds; amorphous solid dispersions, spray-dried intermediates).
- Ability to influence cross-functional technical decisions; mentor scientists.
Additional Information:
- Travel: 0–10%.
- Location: On-site, Indianapolis, IN; Lilly Technology Center-North (LTC-N).
- Anticipated wage: $148,500–$257,400; may be eligible for company bonus and a comprehensive benefits program (e.g., 401(k), medical/dental/vision, life insurance, time off, well-being benefits).