Associate Director, Analytical Chemistry
The Associate Director, Analytical Chemistry will drive creation of analytical methodologies, generation of validation protocols/reports, and product specifications within the CMC group. The Associate Director, Analytical Chemistry is a subject matter expert in chromatography, dissolution, and various physicochemical drug characterization techniques. Other significant areas of knowledge should include organic chemistry and molecular fate, mass spectrometry, and NMR.
Duties & Responsibilities:
- Work effectively with Venatorx project teams and external vendors to assist in development of methodologies for analytical characterization of raw materials, intermediates, drug substances and drug products that are phase appropriate and aligned with manufacturing, development, and commercial requirements.
- Utilize internal and external resources, to:
- Develop and implement appropriate analytical methods for the characterization of raw materials, process unit operations, isolated intermediates and finished products (on release and storage).
- Troubleshoot methods and provide technical guidance to external partners.
- Review analytical method qualification/validation/technical-transfer documentation (test protocols, methods, and reports) for accuracy and completeness.
- Lead in development and justification of specifications, analysis of release data and investigation/resolution of OOS events.
- Manage creation of relevant CMC sections for INDs and their updates, and the preparation and updating of the stability and analytical sections of NDAs.
- Interface with internal stake holders and assist with analytical testing of materials used in GLP pre-clinical and clinical studies.
- Manage design and execution of investigative formulation and drug product performance studies.
- B.S. in Chemistry or Pharmaceutical Sciences with at least 10 years of relevant experience, or a M.S. with 8 years of relevant experience, or a Ph.D. with 5+ years of relevant experience.
- Thorough knowledge of Regulatory guidance including FDA, EMEA, ICH, etc.
- Strong communication and analytical skills
- Able to work independently, with minimal supervision, to develop methodologies and analytical investigation strategies.
- Careful experimentalist with high attention to detail and scientific integrity.
- Self-starter and a team player that will thrive in a small corporate environment.
Equal Employment Opportunity/M/F/disability/protected veteran status