Director, Analytical Development

Menlo Park, California
Jun 08, 2021
Biotech Bay
Required Education
Position Type
Full time
Job Description

This position will provide organizational and technical leadership for the Analytical Development function that supports Corcept’s drug development programs. This position will have end-to-end oversight of all analytical development, methods qualification/validation, and QC testing of intermediates, drug substance and drug product at contract laboratories, and will be responsible for authoring analytical sections of regulatory submissions.

Essential Duties/Tasks
  • Lead the analytical department that is responsible for overseeing development, validation, and transfer of analytical test methods, and QC testing at contract laboratories.
  • Develop strategies and implement analytical testing plans for intermediates, drug substance and drug product that are phase appropriate and in compliance with regulatory requirements.
  • Collaborate with other internal functions and external vendors to establish specifications for drug substance and drug product.
  • Implement plans to ensure that new chemical entities and reference standards are adequately characterized.
  • Develop strategies for selection of contract laboratories.
  • Collaborate with Regulatory to develop strategy for regulatory submissions. Author and review regulatory submissions.
  • Collaborate with other internal groups and external contract laboratories to ensure overall program goals are achieved.
Education and Experience
  • MS or PhD in Chemistry or equivalent scientific discipline.
  • 15+ years experience in analytical methods development supporting small molecule and solid oral dosage development programs.
  • Must have experience developing new chemical entities from early phase to commercialization.
  • Must have at least 5 years experience managing an analytical group and leading the analytical function in a company.
Skills, Qualifications, or Technical Proficiencies
  • Strong background in analytical development and technical program management, as well as expertise in cGMPs, ICH, USP, EP and other relevant regulatory requirements.
  • Experience in setting strategies and authoring analytical sections of regulatory submissions.
  • Experience in OOS and OOT investigations. Able to facilitate timely resolution of these investigations at contract laboratories.
  • Proven expertise in analytical development for leading multiple programs.
  • Strong oral and written communication skills
  • Strong leader with experience in managing a technical group but also enjoy hands-on work.