Regulated BA Analyst

Massachusetts  ‐ Onsite
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Description

Summary:
  • Oversight of instrument installation and organization of laboratory space.
  • The scientist should require minimal training and will support methods run on the instruments and participate in the maintenance of the instruments.
  • Develop and validate ligand binding assays for regulated study support.
  • In addition, the scientist will also conduct sample testing in support of regulated studies, maintain a GLP/GCLP compliant laboratory, and perform routine equipment maintenance and calibration.
SKILLS:

Requirements:
  • Experience with large molecule/biotherapeutics preferred. LC-MS experience not necessarily needed.
  • 1 year of direct Pharma experience also desired.
  • Bachelor's degree required.
  • Candidates should have 2 to 4 years experience with ligand binding assays (ELISA, electrochemiluminescence, fluorescence - Gyros platform) for routine sample analysis.
  • Prior experience with regulated (GLP and/or GCLP) studies is desirable.
  • The candidate will need routine sample analysis using immunoassay techniques.
  • Looking for someone with large molecule/biotherapeutic experience with proficiency in developing/validating ligand binding assays in a biohazardous Matrix (serum, plasma) and/or running LBAs for routine sample analysis in support of pharmacokinetic/toxicokinetic studies.
  • The ligand binding assays would be to quantify a drug candidate, a biomarker for the drug candidate, and/or detecting an immune response to a drug candidate.
  • Someone with ~3 years of pharma experience and/or has worked under GLP regulations is ideal.
  • While they may have some proficiency in ligand binding assays (ELISA), that aspect of work did not appear to be used routinely.
Start date
n.a
From
Synectics
Published at
07.12.2015
Project ID:
1032264
Contract type
Freelance
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