Transform Preclinical Biotherapeutics into Investigational Products for Human Trials. Expertise includes: Process & Analytical Development | Clinical Manufacturing & Supply | CMO Management | Regulatory Filings.Dedicated biotechnology executive with experience at start-up and mid-sized biopharma companies developing, formulating, and manufacturing drug substance and drug product for Phase 1 and Phase 2 human clinical trials. Recognized for applying creative solutions to challenging development problems. Adept at working independently or collaboratively with cross-functional product teams. Collaborate with FDA to advance clinical development via IND submissions and Type A, B, and C meetings.
Listed skills include Sop, Gmp, R&D, Drug Development, and 36 others.