This position will be working in a fast-paced analytical development team supporting small molecule development projects. The title will be commensurate with experience.
Duties and Responsibilities
• Method development, qualification/validation (primarily HPLC, GC, Karl Fischer)
• Some characterization of impurities by LC/MS, GC/MS, and/or NMR.
• Understanding of current CMC project activities and deliverables and responsibility for analytical activities for assigned project(s)
• Oversee release and stability testing of drug substance and drug product
• Provide substantial scientific and compliance inputs for other development documents, such as validation protocols/reports, technical reports, patents, etc.
• Accurate documentation of experimental details, as well as capability to critical review and approve the work of others for accuracy and compliance
• Collaborate with related functions, including primarily chemical and pharmaceutical development colleagues
• Direct, coordinate and monitor activities at contract labs
• Supervision of direct report(s), commensurate with prior experience
• Occasional travel to support analytical testing and audits at contract labs
• Ph.D. in related discipline with minimum of two years of relevant analytical experience
• M.S. in related discipline with minimum of five years of relevant analytical experience
Skills and Experience:
• Technical proficiency in at least two areas of analytical development (compendial testing, separation sciences, spectroscopy and hyphenated technology)
• Prior experience working in a regulated laboratory setting (GMP/GLP) in compliance with internal guidelines and SOP’s
• Prior experience in using Waters Empower data acquisition and analysis platform preferred
• Knowledge of scientific principles, laboratory skills and a commitment to laboratory safety, as well as the capability to effectively and critically apply these in daily activities
• Excellent oral and written communication skills
• Capability to work independently and to multi-task effectively
• Capability to develop and maintain strong cross-functional relationships
Possible direct supervision of Research Associate(s).
The incumbent may be required to sit, stand and walk for extended periods of time. The incumbent may be required to climb, bend, lift, carry and kneel. Because of the volume of work performed by computer and telephone, the incumbent will spend a considerable amount of time looking at the computer monitors and using his/her hands to operate office equipment.
The incumbent would be working in the laboratory approximately 50% of the time.
The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.