Associate Director Analytical Development
* Located in San Francisco
* Competitive Compensation Package
The Associate Director will have the following Responsibilities:
* Responsible for leading analytical development projects within the CMC team, including but not limited to collaborating with CMOs to ensure methods are developed and qualified.
* Review analytical documents data for raw materials and intermediates
* Provide input and coordinate the development, qualification/validation, and/or transfer of analytical methods at global CMOs to meet project timelines
* Responsible for writing drug product-sections related to analytical in the IND, IMPD, and NDA.
* High focus on drug substance analytical development and also contribute in a team environment to solve CMC problems.
* Ensure all analytical testing of drug substances and drug products in clinical development is completed according to timelines
The Ideal Candidate will have the following skill set:
* PhD required, ideally in Chemistry or a related field
* 7+ years Small Molecule Analytical Development experience
* Familiar with all phases of clinical development, ideally targeting strong late-stage experience
* Familiar with Analytical Techniques: HPLC (most important), LC-MS, Karl Fischer, GC
* Prior experience drafting regulatory documents.
* Preference for drug substance over drug product but either and/or both are accepted
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