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Senior Research Scientist (Radiochemistry)

Lantheus
United States, Massachusetts, Billerica
331 Treble Cove Road (Show on map)
Nov 05, 2024
Description

Lantheus is headquartered in Bedford, Massachusetts with offices in New Jersey, Canada, and Sweden. For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and has helped physicians enhance patient care with its broad product portfolio.

Lantheus is an entrepreneurial, agile, growing organization that provides innovative diagnostics, targeted therapeutics, and artificial intelligence (AI) solutions that empower clinicians to find, fight and follow disease. At Lantheus our purpose and values guide our behaviors in all interactions and play a vital role in creating a dynamic environment that contributes to our success. Every employee is crucial to our success; we respect one another and act as one knowing that someone's health is in our hands. We believe in helping people be their best and are seeking to bring together a diverse group of individuals with different viewpoints and skill sets to be a part of a productive and inclusive team.

Summary of role

We are seeking a Senior Research Scientist (Radiochemistry) with expertise in Radio pharmaceutical Development for both diagnostic and therapeutic drug products. The Senior 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.

Key Responsibilities/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 more than 75% of equipment/automation systems (e.g. TRASIS ALLinONE, Neptis, GE Fastlab) and authors close-out reports.
  • In addition, will contribute to the writing of regulatory filing sections.
  • Contributes to selection and implementation of new systems and experimental design.
  • Handling of positron and gamma radionuclides (F18) for small scale radiolabeling experiments of both research and commercial products.
  • Data interpretation, issue resolution as needed and final report writing is required to ensure acceptability of materials manufactured by or for Lantheus.
  • Applies an ability to evaluate data, identify unusual results and design studies that address or expand the understanding of the process being studied.
  • 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.
  • Become familiar with and utilize Laboratory and Documentation Operations, including: archiving systems, Radionuclide database, SOP systems, CMC submission document preparation within R&PD, training modules and long-term strategic goals.
  • Strong organizational, presentation and communication skills, both written and oral.
  • Actively promotes safety rules and Always demonstrates good safety practices including the appropriate use of protective equipment. Reports and takes initiative to correct safety & environmental hazards.


Basic Qualifications



  • BS/BA/MS/PhD in Chemistry, Radiochemistry, Pharmaceutics, Engineering or
  • Typically requires 4-6 years directly related experience with a PhD degree, 6-10 years with an MS degree or 10-14 years with a BS degree.
  • Position will require competency in use of automated radiolabeling synthesis modules.
  • Previous experience with Radiochemistry preferred.
  • Previous experience with contributing to regulatory filing preferred.
  • Experience working in a GxP
  • This position is site-based and requires a presence on-site in our Billerica location five days per week.


Other Requirements



  • 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


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.

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