Support the design, performance and documentation of research/GxP studies to support the development of new and improved analytical methods and active pharmaceutical ingredient process development and radiolabeling processes; physicochemical characterizations in support of process or formulation development; technology transfer to API and PET Contract Manufacturing Organizations. Performs studies to support the optimization of analytical methods, optimization of radiolabeling, identification of impurities and degradation products formed during API synthesis and radio-synthesis, and stability testing of APIs and drug products. Supports the testing of APIs and clinical trial materials by CMOs including: setup, training, qualification of analytical methods, equipment and analysts, and troubleshooting of testing and production issues. Supports Quality investigations resulting from testing and/or production issues.
Key Responsibilities/Essential Functions
Develops, validates and implements analytical methods to support API and drug product process development, release testing, and stability testing.
With direction, designs, develops and troubleshoots processes that utilize complex equipment, experiments and systems in collaboration with other team members.
Understands and applies GxP principles to all aspects of experimentation and technical transfer while documenting results to current industry standards.
Applies an ability to evaluate data, identify unusual results and with direction, designs studies that address or expand the understanding of the process being studied.
Develops and delivers technical presentations to group with direction.
Prepares written reports on all phases of laboratory and/or field experimental work with direction.
Actively promotes safety rules and awareness. Demonstrates good safety practices at all times including appropriate use of protective equipment. Reports and takes initiative to correct safety & environmental hazards.
Actively demonstrates the values of accountability, collaboration, quality, customer service, efficiency and safety.
BS in scientific discipline such as Chemistry or Biology with 6 to 8 years of experience in drug analysis or drug product development, or pharmaceutical development or MS in relevant area with 2+ years' experience or equivalent.
Experience in radio-chemistry, or other related laboratory research preferred.
Handling of and/or exposure to potentially hazardous chemical and/or radiological materials. Required to follow all safety procedures, and use personal and protective equipment provided.
Expertise in the logical design and review of analytical, pharmaceutics and/or validation experiments.
Travel up to 20% may be required
Expertise in regulatory requirements for job functions and extended group functions, expertise with regulatory requirements for drug development.
Routine and/or frequent lifting (30lbs).