RB Prod Tech KovJiv API rFVIII Ops III

 

At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where 'Health for all Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.

 

RB Prod Tech KovJiv API rFVIII Ops III 

 

RB Production Technician - KovJiv API rFVIII Ops III – Berkeley, CA

PURPOSE

 

This Union position supports in the manufacture of Bayer's rFactor VIII products (Kovaltry and Jivi) by performing daily cell culture and purification operations in accordance with cGMP and safety regulations to minimize any loss of sales.

 

YOUR TASKS AND RESPONSIBILITIES
 

The primary responsibilities of this role, RB Prod Tech KovJov API rFVIII Ops III, are to:  
 

• 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), and SIP (Steam-In-Place) procedures;
• Performs daily or routine process operations in the cell culture and purification of biotech and biological products (Kovaltry and Jivi). Operates equipment for these processes including:
  • Inoculates and monitors bioreactors. o Processes cTCF material to Continuous Cell Separation (CCS). o 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.

 

WHO YOU ARE

 

Bayer seeks an incumbent who possesses the following:

 

Required Qualifications

 

• Requires completion of two-years college science courses (e.g. biology, chemistry, biochemistry, or microbiology) or a certificate from an accredited biotechnology academy;
• Relevant biotech 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:
  • Cell Culture bioreactor system assembly and use, including control of gas supply to a bioreactor, Micro-sparger assembly, and Anti-Foam Emulsion system. Ability to troubleshoot and control processes;
  • Continuous cell 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