. Drive quality input for tech transfers, CMC activities, and scale-up plans. Oversee batch record review, product release...
with Project Development Teams (PDTs) and adjacent disciplines (including DMPK, CMC, Regulatory, and Clinical Operations..., CMC (for compound inventory tracking), DMPK (for toxicokinetic integration), and Project Management to ensure nonclinical...
, and Commercial teams. General Functions, Specific Responsibilities, and Authority: Review CMC changes and determine regulatory...
looking for people who are determined to make life better for people around the world. Position Overview: The Associate Director, CMC... of experience in a supply chain function within a pharmaceutical environment 2+ years of CMC experience in the biotechnology...
of autologous, allogeneic, and/or in vivo cell therapy products in clinical development. By connecting CMC Program Strategy...: Maintain the integrated supply chain planning view for assigned cell therapy products, connecting CMC development strategy...
commercial drug product disposition. You will also work with colleagues in CMC, Supply Chain Operations, Quality Assurance... and CMC-regulatory Affairs, while serving as an important point of technical contact between Calcilytix and contract...
discovery projects, 1,100+ CMC programs, and 1,397 clinical trials across all phases. Our teams are involved...
with Manufacturing Represent Supply Chain inventory management in program specific CMC meetings Continually define and refine inventory...
and monitor various stability programs · Author, review, and adjudicate relevant CMC sections for US and ex-US regulatory... setting. Familiarity with CMC analytical regulatory requirements and authoring of IND/IMPD/BLA/NDA/MAA filings and responses...
construction estimating support within the Project Controls group of the Construction Management Consultant (CMC) team on a light...