Biopharmaceutical Manufacturing Specialist

12 hours ago


Reston, Virginia, United States Randstad Life Sciences US Full time
Job Title: Biopharmaceutical Manufacturing Production Specialist

Join Randstad Life Sciences US in Berkeley, CA, as a Biopharmaceutical Manufacturing Production Specialist. This role is part of a multinational biopharmaceutical company's 46-acre biologics manufacturing campus.

Key Responsibilities:

  • Prepare process equipment, including bioreactors, stainless steel tanks, and ancillary equipment.
  • Clean and sterilize equipment using CIP and SIP procedures.
  • Perform daily process operations in cell culture and purification of biotech and biological products.
  • Operate equipment for processes, including inoculation, monitoring, and processing of bioreactors.
  • Process cTCF material, operate chromatography, MAEF, MAVF, and TFF skids, and perform PEGylation of JIVI in process material.
  • Operate automated bagging systems, blast freeze product for storage, and dispense chemicals and formulate solutions.
  • Perform aseptic operations, take and analyze samples, and monitor and control operations with computer control systems.
  • Complete routine check sheets, clean equipment, and maintain clean and orderly production facilities.
  • Perform in-depth troubleshooting and root cause analysis of equipment and process failures.
  • Contribute to continuous improvement opportunities and perform all operations in compliance with cGMP.

Requirements:

  • BS in a science-related field or completion of two years of college science courses in biology, chemistry, biochemistry, or microbiology.
  • Relevant bio-tech industry experience in cell culture, bioreactor systems, and purification processes.
  • Experience with cGMP and GDP requirements for pharmaceutical manufacturing.
  • Ability to lift 45 lb and work in a fast-paced environment with changing shift schedules and off-hour coverage.
  • Independent thinking and decision-making skills, with the ability to make logical decisions independently.

Preferred Skills and Experience:

  • Experience with data integrity, regulatory requirements for pharmaceutical manufacturing, and operation of thermo SUM, 200L, and 2000 bioreactors.
  • Experience with business IT systems, Microsoft Office, and excellent computer skills.


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