Director, Dissolution & Biopharmaceutics - Small Molecules

BioSpace; Indianapolis (IN); On-site; USD 149,000 - 257,000; Full time

Job summary

Lilly, headquartered in Indianapolis, IN, seeks a Director/Senior Director/ED to lead the dissolution science and biopharmaceutics for small molecule drug products from early development through commercialization. You will build strategies, justify methods, and author regulatory content for global submissions while guiding a 1–5 person team.

You will collaborate with formulation, analytical, engineering, ADME, clinical pharmacology, and regulatory teams to drive product performance and ensure

Qualifications

• Ph.D. in Pharmaceutical Sciences or equivalent with extensive industry experience in drug product development and regulatory submission.
• Hands-on leadership in dissolution science/biopharmaceutics and product performance across development to regulatory submission.
• Proven experience with biowaivers, IVIVC/IVIVR, and regulatory content for CTD modules.

Responsibilities

• Lead dissolution science and biopharmaceutics strategy for small molecules from early development to commercialization.
• Author and defend regulatory content, including CMC sections and biopharmaceutics discussions for global submissions.
• Mentor a small team and influence cross‑functional teams across formulation, analytical, engineering, and regulatory groups.

Skills

Technical leadership

Dissolution science

Biopharmaceutics

Cross-functional leadership

Regulatory content

Education

Ph.D. in Pharmaceutical Sciences

M.S. in related discipline

B.S. in related discipline

Tools

GastroPlus

Simcyp

DDDPlus

STELLA

Job description

Lilly, headquartered in Indianapolis, IN, seeks a Director/Senior Director/ED to lead the dissolution science and biopharmaceutics for small molecule drug products from early development through commercialization. You will build strategies, justify methods, and author regulatory content for global submissions while guiding a 1–5 person team.

You will collaborate with formulation, analytical, engineering, ADME, clinical pharmacology, and regulatory teams to drive product performance and ensure