Company: Randstad USA
Posted on: June 24, 2022
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.
- 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
- 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
Education & Qualifications
- BS/BA/MS in Chemistry, Pharmaceutics, Engineering or
- 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
- 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
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