Principal Investigator, Chemical Development
Responsible for research and development, tech transfer and commercialization of drug substance processes, as well as oversight of batch manufacturing and regulatory document contribution through managerial and individual input. Provides project management for Chemical Development projects.
ESSENTIAL DUTIES AND RESPONSIBILITIES (include, but are not limited to):
Plans and manages projects. Represents Chemical Development on cross-functional teams. Maintains accountability for deliverables and progress on R&D and manufacturing plans for Chemical Development projects.
Independently designs, plans and executes activities towards the goals of one or more Chemical Development projects to support preclinical through commercial activities.
Supervises laboratory work and/or lab personnel and ensures safe laboratory practices.
Performs process R&D and optimizes synthetic routes.
Creates and implements novel ideas in Chemical Development.
Provides support for off-site synthesis, manufacturing activities and interaction with contractors.
Provides input into CMC regulatory documentation and supporting work.
Provides effective supervision of laboratory personnel and guidance for their professional development.
Contributes to development of policies and department strategies.
Builds and enhances internal and external professional relationships.
Thorough understanding of organic chemistry and a well-developed understanding of process chemistry as well as current literature.
Excellent interpersonal skills with strong oral and written communication abilities.
Excellent laboratory and productivity skills.
Manufacturing experience in Chemical Development.
Good understanding of cGMP requirements in API.
Demonstration of cross-functional understanding related to drug development.
EDUCATION and/or EXPERIENCE:
Minimum of a Ph.D. in chemistry with 3 years’ experience in the pharmaceutical/process development field, or an M.S. in chemistry with 5 years’ experience.