JVT Advisors

QC Associate I, Bioassay

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Location: Cambridge, Massachusetts 02139
Employment Type: Contract

Job Description

Contract Length:  6+ months

Job Summary:  Reporting to the Supervisor of Quality Control (Bioassay), the Bioassay Quality Control (Contract) Associate I will support cGMP Bioassay method transfer, qualification, validation and release testing for QC raw material, drug substance and finished product testing for mRNA products produced at the manufacturing facility and affiliated contract organizations.

 

Responsibilities:

  • Execute GMP QC Molecular Biology methods, focusing on molecular and protein analytics, but also supporting ELISA, Cell-Based Potency testing, and other methodologies as needed.
  • Support testing for in-process samples, drug substance and drug product, including generation of testing data to support clinical studies.
  • Assist in development, implementation and maintenance of general laboratory operational systems in accordance with cGMP requirements.
  • Perform general laboratory support activities including reagent preparation, equipment maintenance, etc.

Requirements:

  • 5+ years Quality Control experience, BS in a relevant scientific discipline preferred, in a cGMP organization with a focus in Molecular Biology
  • Hands-on experience with molecular biology techniques including, but not limited to, gel electrophoresis, qPCR, etc.
  • Understanding of Sanger Sequencing
  • Working knowledge of relevant and current FDA, EU, ICH guidelines and regulations preferred

Jared Potter

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