Director, Analytical Development
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.
- 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.
- 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.