Director, Analytical Chemistry
The Director of Analytical Chemistry will be responsible for providing oversight for all the analytical development activities associated with drug substance and drug product to support preclinical studies, clinical development, and registration. The incumbent will be responsible for ensuring oversight of all the development activities and testing performed by contract laboratories, including starting materials, in-process, release, and stability testing through early development to pre-commercial.
Role and Responsibilities (include, but not limited to):
- Responsible for the development, validation, and transfers of all analytical methods from pre-clinical through clinical development.
- Participate in selection of CMOs and contract laboratories and oversee development and validation of methods for reference standards, starting materials, intermediates, release and stability testing of both drug substance and drug product.
- Author and provide technical review of relevant Chemistry, Manufacturing and Controls (CMC) sections in regulatory dossiers.
Education and Experience:
- BS/MS degree in Chemistry and 10+ years of pharmaceutical industry experience, or PhD in Chemistry and 7+ years of pharmaceutical industry experience.
- Experience managing analytical CMC development of drug substance and drug products from pre-clinical through registration and approval.
- Expert level knowledge of analytical method development and method qualification/validation
- Strong knowledge of cGMPs.
- Experience interpreting ICH and FDA guidance for analytical method qualification/validation, stability testing.
- Experience authoring analytical modules for regulatory submissions in all phases of development.
- Experience analyzing, interpreting, and presenting technical data for cross functional technical.
- Ability to effectively interact with multiple functions across the organization, and effectively communicate results and strategies to staff and company executives.