Associate Director, Formulation
July 24
🏢 In-office - Bay Area
Description
• Corcept is leading the way in the research and development of cortisol modulators • The Associate Director of Formulation Development will support the drug product development function. • Responsibilities will include leading, planning and managing the technical and business-related activities associated with drug product development and manufacturing of solid oral dosage forms at contract development sites. • Develop strategies and execute plans for drug product development in accordance with timelines and requirements of overall development programs • Work closely with other internal functional groups to ensure that all drug product requirements for clinical trials are met • Prepare CMC sections of regulatory filings.
Requirements
• Technical expertise in solid oral dose formulations for small molecules • Must have hands-on experience in formulating drugs with limited solubility and is knowledgeable about technologies employed to enhance bioavailability • Must have experience in formulation and process development from early to late phase development • Solid understanding of ICH, FDA, EMA guidance in CMC and Quality areas • Good working knowledge of GMP requirements for drug product development and manufacturing • Experienced in writing CMC sections of regulatory filings • Strong written and oral communication skills. Must be comfortable making presentations in team meetings and must have the ability to communicate complex technical information clearly and concisely • Good project management and leadership skills, with ability to lead multiple programs at the same time • Enjoy working in a fast-paced environment within a matrix organization
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