- The Associate Research Scientist will develop new and improved synthesis processes including physicochemical characterizations in support of process or formulation development, radiolabeling processes, research programs and/or technology transfer to Contract Manufacturing Organizations.
- These efforts support the economical, efficient, and safe manufacture of radiolabeling precursors, bulk drug substances, and/or drug products and supports the preparation of experimental drug materials used in extended process design, formulation design and clinical investigations.
- Data interpretation, issue resolution as needed and final report writing is required to ensure acceptability of materials manufactured .
- Position will require competency in use of automated radiolabeling synthesis modules.
- Handling of positron and gamma radionuclides (F18) for small scale radiolabeling experiments of both research and commercial products is also needed.
- Candidate should be familiar with Laboratory and Documentation Operations, including: InfoLinx archiving systems, Radionuclide databases, SOP systems, CMC submission document preparation within
- R&PD, training modules and long- term strategic goals.
- Essential Functions
- With minimal direction, develops procedures, and documents results in open formats.
- Troubleshoots problems with a range of equipment, procedures and, or automated systems.
- Accurately describes results to internal work groups. Demonstrates experience with >75% of
- equipment/automation systems (e.g. TRASIS ALLinONE, Neptis, GE Fastlab) and authors
- close-out reports.
- Contributes to selection and implementation of new systems and experimental design.
- Applies an ability to evaluate data, identify unusual results and design studies that address or expand the understanding of the process being studied.
- Accurately documents results in established formats. Prepares written reports on all phases of laboratory and/or field experimental work with limited direction.
- Demonstrates experience in writing technical documents using templates.
- Understands and applies GxP principles to all aspects of experimentation and technical transfer while documenting results to current industry standards.
- Actively promotes safety rules and awareness.
- Demonstrates good safety practices at all times including the appropriate use of protective equipment.
- Reports and takes initiative to correct safety & environmental hazards.
- Actively demonstrates the Lantheus values of accountability, quality, efficiency, customer service, collaboration and safety.
- BS/BA/MS in Chemistry, Pharmaceutics, Engineering or equivalent.
- Usually requires a minimum of 3 – 4 years directly related experience with a BS degree or 1 – 3years with a Master's degree.
- Experience working in a GxP environment.
-
Associate Research Scientist
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Assoc Research Scientist I, Radiolabeling Synthesis - Billerica, United States - Ehub Global Inc
Description
Title: Assoc Research Scientist I, Radiolabeling Synthesis
Location: Billerica, MA
6-12 month contract
Description:
Summary of Role
Typical Minimum Skills and Experience and Education
