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Bioprocess Manufacturing Technician - 3rd shift openings!

Randstad Life Sciences US
Berkeley, CA Full Time
POSTED ON 1/22/2025
AVAILABLE BEFORE 4/20/2025

Multiple openings for Manufacturing Technicians to work with a multinational, biopharmaceutical company on their 46 acre biologics manufacturing campus in Berkeley, CA.

Position Type : 6 mo. contract through July 2025; potential for extension

Essential Duties and Responsibilities :

  • Cell Culture bioreactor system assembly and use, including control of gas supply to bioreactor, Micro-sparger assembly, Anti-Foam Emulsion system. Ability to troubleshoot and control processes.
  • Continuous Cells Separation equipment preparation and process / controls.
  • Membrane Absorption Chromatography process (e.g. Membrane Absorption process, Buffer and NaOH supply, cTCF supply, Capsule preparation, Inline dilution and Temperature controls).
  • Basic knowledge of protein chemistry and purification systems such as anion, cation, and immunoaffinity chromatography.
  • Membrane Absorber technology, viral removal techniques and tangential flow filtration technology.
  • Large scale chromatography, TFF technology.
  • Familiarity with cGMP’s and applicable agency regulations
  • Prepares process equipment (including but not limited to Bioreactors & ancillary equipment, Stainless Steel tanks, Pressure Transmitters, Flow Meters, Aggregate traps, Harvest discards, Transfer lines (buffers, cTCF), Hoses and small parts.
  • Cleans and Sterilizes equipment using appropriate CIP (Clean-In-Place), SIP (Steam-InPlace) procedures.
  • Performs daily or routine process operations in the cell culture and purification of biotech and biological products (Kovaltry, Kogenate, and Jivi).
  • Operates equipment for theseprocesses including :
  • Inoculates and monitors bioreactors.
  • Processes cTCF material to Continuous Cell Separation (CCS).
  • Operates Chromatography, MAEF, MAVF and TFF skids.
  • Processes MAEF material using closed thaw process, step elution chromatography, Membrane Absorber and filter clearance technology, and gradient controlled SP column separation techniques.
  • Operates 50L, 200L and 1000L collection bag technology to ensure robust collection, mixing and dilution of products.
  • Performs PEGylation of JIVI in process material using TFF technology.
  • Operates automated bagging systems.
  • Blast Freezes product for storage.
  • Dispenses chemicals and formulate solutions.
  • Prepares acids and bases as necessary.
  • Performs aseptic operations.
  • Takes, analyzes and submits samples as required throughout the process.
  • Monitors and controls operation with computer control systems.
  • Completes all routine check sheets.
  • Cleans equipment and maintains clean and orderly production facilities.
  • Performs in-depth troubleshooting and root cause analysis of Kovaltry, Kogenate, and Jivi equipment and process failures.
  • Contributes to continuous improvement opportunities.
  • Performs all operations in compliance with cGMP.
  • Performs other related duties as assigned.

Qualifications :

  • Two-years’ college science courses in (e.g. biology, chemistry, biochemistry, or microbiology), OR
  • Certificate from an accredited bio-technology academy, OR
  • BS in science related field is preferred
  • 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 above
  • Preferred Skills and Experience :

  • Experienced in cGMP and GDP requirements for pharmaceutical manufacturing.
  • Cell Culture bioreactor system assembly and use, including control of gas supply to bioreactor, Micro-sparger assembly, Anti-Foam Emulsion system. Ability to troubleshoot and control processes.
  • Continuous Cells Separation equipment preparation and process / controls.
  • Membrane Absorption Chromatography process (e.g. Membrane Absorption process, Buffer and NaOH supply, cTCF supply, Capsule preparation, Inline dilution and Temperature controls).
  • Basic knowledge of protein chemistry and purification systems such as anion, cation, and immunoaffinity chromatography.
  • Membrane Absorber technology, viral removal techniques and tangential flow filtration technology. Large scale chromatography, TFF technology.
  • Familiarity with cGMP’s and applicable agency regulations
  • Experienced with data integrity, regulatory, requirements for pharmaceutical manufacturing.
  • Experienced in operation of thermo SUM, 200L and 2000 bioreactors, Akta ready XL, Akta ready gradient, and Akta ready Flux XL.
  • Experienced with business IT systems (Delta V, Team, outlooks, SAP etc…)
  • Experienced with Microsoft Office. Excellent computer skills.
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