JVT Advisors

Manufacturing TEch, 3rd shift GMP

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Location: Cambridge, Massachusetts 02139
Employment Type: Contract

Job Description

Contract length: 6+ months

Shift: 3rd Shift

Job Summary:  Responsible for producing high quality mRNA-based medicines for evaluation in human clinical trials. Apply existing and new knowledge of bioprocess unit operations and cGMPs to enable technical success with stringent adherence to a Quality System that respects global regulatory expectations. Able to document and communicate technical and operational observations clearly and efficiently. Able to operate pilot-scale bioprocessing equipment and interact fluidly with peers and supervisors in the Pilot Plant, and cross-functionally with Quality Control, Quality Assurance, Logistical and Process Development Technology Transfer counterparts.

Responsibilities:

  • Strict adherence to current good manufacturing practices, standard operating procedures, and manufacturing documentation.
  • Establish and follow written procedures for the clear and accurate documentation of equipment operation and process instructions, and of process data.
  • Monitor process operations to ensure compliance with specifications.
  • Complete tasks in support of large scale manufacturing, including in the care of high-value capital equipment, such as chromatography and tangential flow filtration systems.
  • Assist in the investigation of procedural deviations.
  • Utilize knowledge to improve operational efficiency.
  • Adhere to Pilot Plant gowning procedures and maintain a clean general operating area.
  • Adhere to documented waste handling procedures to respect environmental regulations.

Requirements:

  • Bachelor’s degree and 0-2 years industry experience in a GMP manufacturing environment.
  • Experience with chromatography, TFF and single-use equipment platforms.
  • Proven track record of success in a fast-paced production environment at a biotech/pharmaceutical company preferably in GMP or GLP
  • Exceptional written, oral communication, and organizational skills required

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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