Principal Scientist
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![]() United States, Massachusetts, Bedford | |
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Description
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
Typical Minimum Skills and Experience and Education
Other Requirements
Core Values: The ideal candidate will embody Lantheus core values:
Lantheus is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Lantheus is an E-Verify Employer in the United States. Lantheus will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Lantheus Talent Acquisition team at talentacquisition@lantheus.com. |