Associate Director, CMC, Drug Substance

Qualification

PhD in Chemistry or other relevant discipline with a minimum of 10 years of directly related experience in a pharma or biotech environment. Candidates with a MSc and significant relevant experience may be considered as well. Demonstrated track record in successfully managing development-stage and/or commercial-stage API manufacturing activities conducted at CDMOs. Strong emphasis will be placed on experience in running initial cGMP deliveries followed by tech transfers to later stage development CDMOs. Experience authoring/co-authoring key CMC sections in U.S. IND/NDA and European MAA filings for small molecule APIs Extensive knowledge of cGMP-related regulations, guidance documents, principles, and best practices pertinent to APIs Strong experience in working within a virtual manufacturing setting that requires knowledge of CDMO landscape and selection, vendor management, contracting, issue resolution and management Excellent written and oral communication skills, including the ability to communicate with scientific and non-scientific personnel and experience in applying risk-based decision-making tools. Excellent oral and written communication and interpersonal skills as well as