Research Lab Specialist Inter (Underfill to Associate)

at  University of Michigan

Ann Arbor, MI 48109, USA -

Start DateExpiry DateSalaryPosted OnExperienceSkillsTelecommuteSponsor Visa
Immediate24 Jan, 2025Not Specified25 Oct, 20241 year(s) or abovePurification,Working Environment,Teams,Regulatory Filings,Corrective Actions,Generators,Communication Skills,Interpersonal Skills,Financial Management Experience,PublicationsNoNo
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Description:

HOW TO APPLY

A cover letter is required for consideration for this position and should be attached as the first page of your resume. The cover letter should address your specific interest in the position and outline skills and experience that directly relate to this position.

JOB SUMMARY

The Division of Nuclear Medicine, Department of Radiology is currently seeking a Research Lab Specialist Intermediate position with an option of Associate underfill. The successful candidate will contribute in a variety of ways, consistent with her/his existing skills and previous experience in support of clinical and preclinical imaging studies, and quality assurance efforts.

REQUIRED QUALIFICATIONS*

  • Education and Experience Intermediate Level: This position requires a minimum of a Bachelor’s degree and 4-5 years related experience; but can be substituted with equivalent education and/or experience.
  • Education and Experience Associate Level: This position requires a minimum of a Bachelor’s degree and 1-3 years related experience; but can be substituted with equivalent education and/or experience.
  • Excellent written and oral communication skills are a must.
  • Excellent interpersonal skills and experience working in a highly collaborative working environment, including the ability to work remotely with teams in different locations.
  • Ability to work independently
  • Hands on experience with the incorporation of fluorine-18, carbon-11 and gallium-68 is strongly preferred, including experience with the generation of radionuclides (from cyclotrons and/or gallium generators) and the synthesis, purification and quality control of PET radiotracers.
  • A verifiable ability to function effectively in a continually changing environment, and to troubleshoot problems and implement corrective actions.
  • Radiochemical syntheses, including chemistry issues and equipment malfunctions associated with the synthesis of PET radiotracers.

DESIRED QUALIFICATIONS*

  • We are looking for a candidate with 1-3+ years of experience in PET radiochemistry or quality control/quality assurance, or PhD degree in (or equivalent) with 0-3+ years of experience in PET radiochemistry or quality control/quality assurance. Can be substituted with equivalent education and/or experience. Supervisory and financial management experience preferred.
  • Relevant research experience in PET radiochemistry is not required but would also be a plus.
  • A strong academic record including publications in peer reviewed journals would be a plus.
  • Experience contributing to regulatory filings such as INDs and (A)NDAs.

Responsibilities:

  • Synthesis and quality control of PET tracers to meet demanding pre-clinical and clinical imaging schedules according to cGMP regulations (USP823 and 21 CFR212).
  • Contribution to regulatory documents required for clinical PET tracer filings such as INDs and (A)NDAs.
  • Assist with regulatory inspections and correspondence with regulatory agencies.
  • Quality and regulatory compliance initiatives and routine monitoring/tracking/trending.
  • Maintenance and upkeep of PET radiochemistry laboratory equipment such as automated synthesis modules and HPLCs.
  • Accurate record keeping for lab books, equipment logbooks and production batch records.
  • Presentation of research results at group meetings (and national meetings if interested).
  • Assist with writing/co-authorship of manuscripts for submission to peer-reviewed journals.
  • Collaborate with PET Center and imaging suite personnel to ensure we meet Michigan Medicine missions of excellence in research, clinical care, and teaching.
  • Exercises greater autonomy in managing the operation of a specialized laboratory within a department or research program. May be responsible for coordination of operation with another department in a research project. Coordinates the processing and analysis of data and the conduct of experimental tests and suggests new or revised research methodologies. Provides input into the development of mathematical and/or computer models for analyzing experimental data. Trains users in equipment operation and laboratory techniques. Explains and demonstrates technology and equipment capabilities, operations limitations and outcomes. Increased responsibility for writing research support proposals and acquiring data from outside agencies.


REQUIREMENT SUMMARY

Min:1.0Max:5.0 year(s)

Pharmaceuticals

Pharma / Biotech / Healthcare / Medical / R&D

Clinical Pharmacy

Graduate

Proficient

1

Ann Arbor, MI 48109, USA