Principal Scientist
1 week ago
The Principal Research Scientist will develop formulations, new and improved drug product synthesis and/or production processes in support of pre-clinical, clinical and initial commercialization project. These efforts include the following studies: physicochemical characterizations that guide process and/or formulation development, developing new and/or improved radiolabeling chemistries, developing semi-prep or cartridge based purification methods and supporting drug product method development activities.
The role includes support and participation in the technology transfer of clinical and initial commercial production processes to Contract Manufacturing Organizations (CMO), as well as participation in technical investigations at CMOs. Support of continuous improvement efforts for commercial products is also included.
Data interpretation, issue resolution, as needed, and report writing is required to support the accurate documentation of development studies and to support regulatory submissions of Lantheus development and commercial products. The position is expected to draft key sections of regulatory submissions.
These efforts support the economical, efficient, and safe manufacture of radiolabeling precursors, bulk drug substances, and/or drug products and supports the preparation of pre-clinical, clinical and initial commercial materials.
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 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 protocols and close-out reports.
- Contributes to selection and implementation of new systems and experimental
- Applies an ability to evaluate data, identify unusual results and design studies that address or expand the understanding of the process being
- Accurately documents results in established Prepares written reports on all phases of laboratory and/or field experimental work with limited direction. Demonstrates experience in writing technical documents and Regulatory submissions using templates.
- Understands and applies GxP principles to all aspects of experimentation and technical transfer while documenting results to current industry
- Actively promotes safety rules and 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
- BS/BA/MS/PhD in Chemistry, Pharmaceutics, Engineering or
- Usually requires a minimum of years directly related experience with a BS degree, 10-14 years with a Master's degree or 6 - 8 years with a Ph.D.
- Experience working in a GxP
- Handling of, and/or exposure to, potentially hazardous chemical, radiological and or biological 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
- Expertise with GxP documentation Regulatory requirements: Mastery for job function; intermediate knowledge for extended group functions; basic knowledge for development.
- Routine and/or frequent lifting, up to 30
- Travel may be required as per business
The ideal candidate will embody Lantheus core values:
- Let people be their best
- Respect one another and act as one
- Learn, adapt, and win
- Know someone's health is in our hands
- Own the solution and make it happen
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