Analyst, Bioassay

2 weeks ago

Woburn, United States Tandym Group Full time

Responsibilities:

  • Review and approval of cGMP analytical data for release and stability testing from bioassay test methods including, but not limited to, mRNA expression, functional potency and ELISA testing platforms.
  • Perform data integrity review (i.e. data verification) in support of validation, qualification, and analytical method trending reports, as needed
  • Support execution of routine Bioassay laboratory operations including, but not limited to:
  • Review of logbooks (reagent preparation, equipment, critical reagent tracking),
  • Performance of weekly laboratory housekeeping walkthroughs
  • Preparation of reagents
  • Cell Passaging
  • Author and support quality events; Change controls, Deviation, CAPA, OOS Investigation, as needed.
  • Author analytical method performance trend reports, as needed.

Qualifications:

  • BS in Cell Biology, Molecular Biology, Biochemistry or a related discipline with 5+ years industry experience
  • Experience in mammalian cell culture and biological methods in one or more of the following areas: immunoassays, cell-based assays, and quantitative PCR methods
  • Experience in a GMP/GLP environment is a must.
  • Experience with statistical analysis software (SoftMax, JMP) preferred
  • Ability and desire to work in a fast-paced environment
  • Strong collaboration, team-working skills, and communication skills
  • Independently motivated and detail-oriented with good problem-solving ability
  • Strong communication, interpersonal and organizational skills

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