Associate Director, CMC Drug Product
Location
Salt Lake City, Utah
Level
Senior
Department
Operations
Type
Full - Time
Salary
Job Description
Posted on:
April 17, 2023
As CMC Drug Product Associate Director, you will be an essential member of the Recursion CMC Team reporting to the Director of Drug Product Development. The CMC Team is an empowered, execution-minded group of scientists and technical experts responsible for translating Recursion’s innovative science to patients in the clinic through CMC activities and deliverables.
Responsibilities
- Lead external drug product development across select portfolio candidates including oversight of CDMOs and strategic technical development relationships
- Provide technical authoring of internal reports and regulatory filings supporting Recursion’s clinical programs
- Ensure delivery of formulated drug product from external manufacturing campaigns adhering to current quality guidelines and delivery timelines
- Critically analyze development, manufacturing, and analytical data and batch records to identify and resolve formulation challenges during drug product development
- Participate in developing and extending our CDMO relationships for drug product expenditures and achieving our quality requirements
Job Requirements
- Ph.D. in pharmaceutical sciences, chemical engineering, or closely related field with a minimum of 5-8 years’ experience or M.S. with 8-12 years of experience
- Knowledge of and experience in oral solid dose formulation development and manufacturing particularly across Phase I to Proof of Concept
- Experience leading external development and CDMO relationships is a plus
- Cross-functional understanding related to formulation development including pre-formulation, solid state, analytical results, stability trending, quality and regulatory affairs
- Well-versed with the latest trends in drug formulation technologies and the outsourcing industry
- Demonstrated track record in the areas of drug product development (authoring of CTD sections) with prior IND/IMPD authoring experience preferred
- Ability to travel to external manufacturing sites 10-20% of the time
