Analytical Chemistry lead for Chemistry, Manufacturing and Controls (CMC) function (Drug Product and Drug Substance) delivering comprehensive, state of the art, physicochemical characterization of pharmaceutical products and processes and providing strategic direction and support to manufacturing, Operations, R&D, Clinical, Regulatory, and Quality.
- Work effectively with VenatoRx project teams, including CMC, Quality, Regulatory, and Development to develop strategic approaches to the analytical characterization of raw materials, intermediates, drug substances and drug products that are phase appropriate and aligned with manufacturing , development, and commercial requirements.
- Manage execution of analytical strategy, leveraging 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 across development programs, including preclinical and clinical stage programs
- Ensure analytical method qualification/validation/technical-transfer documentation (test protocols, methods and reports) are relevant, accurate and complete.
- Provide oversight of all analytical chemistry aspects of manufacturing including development and justification of specifications, analysis of release data and investigation/resolution of OOS events.
- Prioritize and manage internal analytical development activities
- Manage the scientific, regulatory, quality and budgetary aspects of all analytical chemistry contractors.
- Manage analytical testing of materials for clinical trials. This includes on-site support of CRO-related activities and review/release of batch records for CTM.
- Coordinate all CMC aspects of the analytical development program with other functional areas.
- Develop stability protocols, review stability data, and manage stability programs in conjunction with Quality.
- Ensure provision of the relevant CMC sections for INDs and their updates and the preparation and updating of the stability and analytical sections of NDAs.
- BS in chemistry, with an advanced degree in analytical chemistry preferred
- 12-15 years of experience in analytical chemistry in the pharmaceutical/and or biotechnology industry
- Experience with contract labs or managing outsourcing in a drug development industry, stability studies for pharmaceutical products, HPLC method development and validation, project management, API manufacturing, technical/regulatory writing and audits.
- Strong organizational and communication skills.
- Self-starter and a team player who will thrive in an entrepreneurial environment.
- Experience in late phase development activities, e.g. analysis of drug product supplies for pivotal clinical trials, registration stability studies, and process validation.
- Expertise in the development and validation of analytical methods used for the characterization and control of parenteral products.
- Experience authoring Investigational New Drug (IND), New Drug Applications (NDA) and responding to CMC questions from FDA/international regulatory authorities.
The position will be located in the Malvern, PA office.