JVT Advisors

Sr. Associate, Quality Control Bioassay

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Location: Cambridge, Massachusetts 02139
Employment Type: Contract

Job Description

Contract Length: 6+ months

Job Summary: Reporting to the Manager of Quality Control (Bioassay), the Bioassay Quality Control (Contract) Sr. Associate will be responsible for supporting bioassay method transfer, qualification, validation and GMP release testing for QC raw material, drug substance and finished product for mRNA products produced at the company’s GMP manufacturing facility and affiliated contract organizations.

Responsibilities:

 

  • Support bioassay testing for raw materials, drug substance and drug product, including generation of testing data to support clinical studies.
  • Collaborate with development groups for method transfers and qualifications in support of expanding the QC Bioassay laboratory capabilities, including Sequencing and qPCR assays as required.
  • Train junior laboratory staff on Molecular Biology methods
  • Write/revise SOPs, protocols and reports

Requirements:

  • BS in a relevant scientific discipline with at least 2+ years Quality Control experience in a cGMP organization with a focus in Molecular Biology and DNA Sequencing
  • Working knowledge of relevant and current FDA, EU, ICH guidelines and regulations
  • Knowledge and hands-on experience performing and troubleshooting Sanger Sequencing
  • Demonstrated knowledge of method qualifications
  • Excellent troubleshooting and ability to communicate issues in a scientifically sound and understandable way

 

Michael Liuzza

Senior Recruiter

As a Senior Recruiter, Michael Liuzza brings almost a decade of sourcing and hiring experience to the JVT team. In his current role, Michael is responsible for full lifecycle recruiting, partnering with JVT's Contract Recruiting Team to match superior available talent with career building opportunities.

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