Associate Director - CMC Product Manager
August 28
🏡 Remote – Anywhere in California
Description
• IDRX is a clinical-stage biopharmaceutical company dedicated to transforming cancer care with intelligently designed precision therapies. • Reporting to the head of Pharmaceutical Sciences, this position is cross-functionally focused throughout CMC, as well as with external partners and suppliers. • The role will manage internal and external CMC centric collaborations and drive IDRx CMC program progression throughout clinical development and commercial. • This candidate will be responsible for the coordination of planning and oversight of execution of all integrated activities related to the budgetary planning, development, manufacturing and packaging of small molecule solid oral drug formulations. • It will also manage the integration of CMC plans from pre-IND/IMPD through NDA/MAA, in support of IDRX clinical and commercial programs. • This is an excellent opportunity to join a small, nimble team and have substantial impact across the organization.
Requirements
• BS or MS and 5-10 years of experience working in a biotech or pharmaceutical setting • Experience managing people, and leading and fostering development on their team • Skilled in establishing, maintaining, and managing relationships with CROs, CMOs and testing labs • Comprehensive understanding of small molecule and solid oral dosage form development, regulatory and quality • Experienced in late-stage program development including registration stability and process validation strategies • Excellent communication skills, both written and verbal, keeping key stakeholders and management informed of status, issues and recommended solutions • PMP certification is a plus • Ability to travel 10%-15%, as required
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