Job Details

  • Title: Process Development Technician
  • Code: RCI-PFE-16425-1
  • Location: Andover Massachusetts (MA) 01810
  • Posted Date: 08/14/2019
  • Duration: 12 Months
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  Job Description

Must have purification process experience
shift hours (Mon-Fri, 2:30pm-12am)

  • Set-up and execution of cGMP unit operations with a focus on Purification (Chromatography, flow through filtration, tangential flow filtration) and solution formulation. Includes cleaning and sanitization of the facility and equipment (CIP, SIP, COP, autoclaving, depyrogenation, etc)
  • Accurately¬†follow oral, written and electronic instructions in the production area and document daily operations in GMP batch records and logs
  • Operate manual and automated equipment
  • Individuals will be expected to learn and work with enterprise systems such as LabWare LIMS and SAP
  • Support implementation of new technology for process execution and/or analysis.¬†May be responsible for authoring and revising cGMP documents including batch records and SOPs
  • Responsible for data entry and real-time process monitoring
  • Assist in inventory tracking, maintenance scheduling, and troubleshooting of mechanical equipment
  • The Process Technician will be responsible for the execution of Purification, Buffer preparation and glass wash activities in a multi-product, multi-line cGMP facility capable of manufacturing commercial, clinical and a development drug substance
  • Successful candidates will be flexible and adaptable, willing to work in a fast-paced, dynamic environment
  • Years of Experience 3-5
  • Experience with chromatography columns, UF, and VRF systems, and final fills are preferred
  • HS Diploma + 3 years of experience or Associate Degree + 1 year of experience