Analytical Scientist

Company: Randstad USA
Location: Billerica
Posted on: June 24, 2022

Job Description:

Analytical Scientist IPERMNorth Billerica, MA
Job SummaryAnalytical Chemist/Scientist to develop new and improved analytical methods and 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 analytical analyses, 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 HPLC, UV, radio-detection, MS and TLC methodology. Handling of positron and gamma radionuclides (F18, Ga67, In-111, Tc99-m) for small scale radiolabeling experiments and analytical analysis 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.
Job Responsibilities

• 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. HPLC, UV, MS, radio-detectors) 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.
  Education & Qualifications
  • BS/BA/MS in Chemistry, Pharmaceutics, Engineering or equivalent.
  • 3 - 5 years experience
  • Experience working in a GxP environment
  • Handling of, and/or exposure to, potentially hazardous chemical, radiological and or biological 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.
  • Expertise with GxP documentation requirements. Regulatory requirements: Mastery for job function; intermediate knowledge for extended group functions; basic knowledge for development.
  • Routine and/or frequent lifting, up to 30 lbs.
  • Travel may be required as per business need.

Keywords: Randstad USA, Billerica , Analytical Scientist, Other , Billerica, Massachusetts