Biotech Manufacturing Specialist

1 week ago

Berkeley, California, United States HarveStaff Full time

Job Summary

HarveStaff is seeking a highly skilled Biotech Manufacturing Technician to join our team. As a Biotech Manufacturing Technician, you will be responsible for the assembly and operation of bioreactor systems, including control of gas supply, micro-sparger assembly, and anti-foam emulsion system.

Key Responsibilities

  • Assemble and operate bioreactor systems, including control of gas supply, micro-sparger assembly, and anti-foam emulsion system.
  • Prepare and operate continuous cell separation equipment, including process controls.
  • Operate membrane absorption chromatography process, including buffer and NaOH supply, cTCF supply, capsule preparation, and inline dilution and temperature controls.
  • Operate membrane absorber technology, viral removal techniques, and tangential flow filtration technology.
  • Perform large-scale chromatography and TFF technology operations.
  • Familiarize yourself with cGMPs and applicable agency regulations.
  • Prepare process equipment, including bioreactors, ancillary equipment, stainless steel tanks, pressure transmitters, flow meters, aggregate traps, harvest discards, transfer lines, hoses, and small parts.
  • Clean and sterilize equipment using CIP and SIP procedures.
  • Perform daily and routine process operations in cell culture and purification of biotech and biological products.
  • Operate equipment for these processes, including inoculation and monitoring of bioreactors, processing of cTCF material to CCS, operating chromatography, MAEF, MAVF, and TFF skids, processing MAEF material using closed thaw process, step elution chromatography, membrane absorber, and filter clearance technology, and gradient controlled SP column separation techniques.
  • Operate 50L, 200L, and 1000L collection bag technology to ensure robust collection, mixing, and dilution of products.
  • Perform PEGylation of JIVI in process material using TFF technology.
  • Operate automated bagging systems.
  • Blast freeze product for storage.
  • Dispense chemicals and formulate solutions.
  • Prepare acids and bases as necessary.
  • Perform aseptic operations.
  • Take, analyze, and submit samples as required throughout the process.
  • Monitor and control operation with computer control systems.
  • Complete all routine check sheets.
  • Clean equipment and maintain clean and orderly production facilities.
  • Perform in-depth troubleshooting and root cause analysis of kovaltry, kogenate, and JIVI equipment and process failures.
  • Contribute to continuous improvement opportunities.
  • Perform all operations in compliance with cGMP.

Requirements

  • Relevant bio-tech industry experience in some or all of the following is preferred and may be considered in lieu of some or all of the educational requirements.
  • Ability to troubleshoot and control processes.
  • Basic knowledge of protein chemistry and purification systems such as anion, cation, and immunoaffinity chromatography.
  • Familiarity with cGMPs and applicable agency regulations.

Education/Training/Certifications

  • Requires completion of two years' college science courses in biology, chemistry, biochemistry, or microbiology, or a certificate from an accredited bio-technology academy.

Additional Requirements

  • Shift: 8:00 PM - 4:00 AM

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