David Heilman
Pharmaceutical Development, CMC, Retired US Army
- Role
- Senior Director, Pharmaceutical Development and Cmc at Nicox
- Location
- Hillsborough, NC, US
- LinkedIn followers
- 500 followers
About David Heilman
Servant leader with demonstrated success in leading people and multiple projects in two very different environments. Accomplished track record of building cross-functional teams in the pharmaceutical industry and US Military. Breadth of knowledge spans the primary pharmaceutical company value chain. Depth of knowledge is leading the drug product development and technical transfer to commercial manufacturer for parenteral (IV, IM and Subcutaneous delivery), topical ophthalmic, nasal and inhaled delivery of large and small molecule drug products. Experience in preparing CMC sections of regulatory documents for US and ex-US regulatory agencies to include Japan, Republic of China, Japan and South Korea.
Experience
Senior Director, Pharmaceutical Development and Cmc
Jan 2025 — Present · Durham, NC, US
Responsible for CMC-related operations across Nicox\'s pipeline including the manufacture of drug product for use in Clinical Trials and to support regulatory filings in the US, China and Japan; the manufacture of drug substance to support drug product manufacturing and regulatory filings; and analytical method development to support release and stability studies for both drug products and drug substances. Also responsible for Clinical Trial Material Supply Chain operations.
Education
West Liberty University
Chemistry and Mathematics
The University of North Carolina at Chapel Hill
Master of Business Administration - MBA, Strategy and Leadership
2017 — 2019
Wheeling University
BS, Chemistry and Mathematics
Ohio University
MS, Chemistry
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