What are the responsibilities and job description for the CMC Drug Substance Director position at Recursion?
The Impact You’ll Make
- Lead the drug substance develop for assigned programs
- Provide technical leadership, project management and oversight of drug substance process development and manufacturing activities supporting Recursion’s clinical programs
- Ensure delivery of drug substance from external manufacturing campaigns adhering to current quality guidelines. Typical travel to external manufacturing sites is around 10-20% of the time
- Critically analyze process and analytical data to identify and resolve key synthetic challenges during drug substance development
- Participate in budget planning and forecasting for drug substance expenditures and ensure budget, schedules, and performance requirements are met
The Team You’ll Join
As CMC Drug Substance Director, you will be an essential member of the Recursion Development Team reporting to the Senior Director of CMC. The Development Team is an empowered, execution-minded group of business development and clinical development professionals responsible for translating Recursion’s innovative science to patients through clinical and business development activities.
The Experience You’ll Need
- Ph.D. in organic chemistry or closely related field with 8 years experience
- Strong knowledge of & experiences in small molecule drug substance process development and manufacturing best practices across all phases of drug development, from initial regulatory filings through registration, validation and launch
- Experience in continuous manufacturing is a plus
- Demonstration of cross-functional understanding related to drug substance development including salt/polymorph screening, phase appropriate analytical development, standard process of drug product development, quality and regulatory affairs
- Well-versed with the latest trends in drug substance technologies and the outsourcing industry
- Demonstrated track record in the areas of drug product development (authoring of CTD sections) with prior NDA/MAA preferred
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