JVT Advisors

Manufacturing Specialist

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Location: Cambridge, Massachusetts 02139
Employment Type: Contract

Job Description

Contract Length: 6+ months

Job Summary: Reporting to the Manager Manufacturing, this individual will be part of a cohesive team responsible for producing high quality mRNA-based medicines for evaluation in human clinical trials. The Manufacturing Specialist uses expert knowledge of cGMP regulations and downstream biopharmaceutical production processes to manage investigations and improvement initiatives within manufacturing operations.

Responsibilities:

  • Practice and promote safe work habits and adheres to safety procedures and guidelines.
  • Utilizes manufacturing process knowledge and investigational skills to identify and resolve manufacturing issues and drive continuous improvement in process operations.
  • Lead cross functional teams to drive complex investigation close outs, determine root causes and implement appropriate corrective and preventive actions.
  • Conducts document revisions and/or document management including batch production records and manufacturing procedures.
  • Performs training with staff on the floor, as needed.
  • Leads cross-functional continuous improvement teams with Engineering, Validation, Quality Assurance, Quality Control, Facilities, and Manufacturing Science and Technology

Requirements:

  • Bachelor's Degree with 5-8 years of experience in biopharmaceutical operations or a Master’s Degree with 0-2 years industry experience; Degree in Engineering or Life Sciences is preferred.
  • Subject matter expertise in biologics drug substance purification operations (liquid chromatography, TFF, aseptic technique) or a similar complex specialized environment.
  • A comprehensive understanding of regulatory requirements and their applications in a cGMP environment.
  • Minimum of 2 years’ experience with deviation/investigation management systems or a similar technical writing system in a cGMP environment.

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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