Location:Watertown, MA,

Primary Responsibilities

• Provide analytical oversight of external vendors for pre clinical and Phase I - III CMC activities for small molecule drug substance (DS) and drug product (DP).
• Develop analytical methods and conduct testing internally.
• Select and manage providers of analytical services, including analytical services embedded in contract manufacturing organizations (CMOs).
• Phase appropriate development, validation and transfer of analytical methods for raw materials, in-process control, DS and DP testing.
• Participate in the development and revision of product specifications; provide scientific input and critique of analytical results.
• Review the quality control testing of clinical trial supplies performed at CMOs.
• Analyze stability studies for DS and DP.Review CMC sections of regulatory submissions along with other functional groups.
• Participate in preparation of responses to regulatory agency questions.Ensure compliance with analytical requirements for CMC regulatory submissions.
• Familiarity with a full range of analytical techniques for characterization of pharmaceuticals including thermal methods, HPLC & GC with a variety of detection methods, wet chemical analysis, spectroscopic techniques, particle size analysis.
• Develop and grow the Analytical Research and Development department in keeping with the needs of the company.

Education, prior work experience, and specialized skills and knowledge

• Advanced degree in pharmaceutical sciences or chemistry.
• Demonstrated CMC experience managing analytical development for small molecule drug substance drug product from Phase I - Phase III.
• Strong analytical, communication, presentation, and writing skills.
• Ability to strategically plan, organize and manage multiple projects simultaneously.
• Ability to exercise independent judgment with minimal supervision.
• Ability to work cross-functionally in a fast-paced team environment.Demonstrated ability to effectively manage outsourced analytical activities.
• Demonstrated experience with regulatory submissions and communication