Biopharm Manufacturing Associate

1 week ago


Cambridge, United States Accuro Full time

Business Title: Biopharm Manufacturing Associate

Location: Cambridge, MA

Job Type: 6 + months contract



PARKING IS ROUGHLY $420/MO


1st Shift: 7:00 AM - 3:30 PM Monday - Friday


***Strong experience of working with any TFF system is a must***

Job Responsibilities

  • Produce pharmaceutical components and products by following current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP) within a cleanroom environment
  • Perform the weighing of manufacturing ingredients and the manufacturing of the intermediate formulations
  • Tasks include documentation, data entry, and computer software with compliant systems --Participation in continuous safety and environmental inspections
  • Maintain continuous inventory control using computerized system
  • Follow aseptic procedures and good documentation practices
  • Follow production schedule and prepare materials for production runs
  • Prepare solutions per production schedule
  • Cleaning, operating, and maintaining GMP equipment
  • Prepare equipment for processing by performing cleaning-in-place (CIP) and cleaning-out-of-place (COP), as necessary
  • Perform equipment inspections to ensure readiness and preventative maintenance, as needed
  • Operate and monitor GMP equipment, adjust equipment controls, perform actions as specified by production batch records (BPRs), adhere to aseptic behaviors, and maintain a safe and clean work environment by following cGMPs
  • Document production by completing forms, reports, logs, and records of equipment batches
  • Maintain up-to-date training records
  • Perform cleaning of production suites daily and as necessary
  • Create and edit production records and documents, as necessary

Skills & Experience Required

  • Associate's degree in relevant field
  • Bachelor's degree preferred
  • 3+ years of experience
  • Experience or understanding of pharmaceutical development
  • Knowledge of cGMP, GDP, USP, and FDA quality guidelines and regulations



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