RB Prod Tech KovJiv API rFVIII Ops III

Bayer CropScience Ltd-posted 2 months ago
Full-time • Entry Level
Onsite • Berkeley, CA
251-500 employees
Chemical Manufacturing
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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.

  • 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.
  • 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.
  • 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-scale chromatography, TFF technology
  • Familiarity with cGMP's and applicable agency regulations.
  • Read, write, speak, and comprehend English in order to understand written and verbal instructions, SOP's, BPR's
  • Good verbal and written communication skills
  • Work weekends, holidays and overtime as required
  • Acceptable attendance and performance
  • Able to work both independently/self-directed with minimal supervision and in a team environment
  • Detail-oriented with the ability to demonstrate good record-keeping practices and the ability to follow data integrity rules
  • Computer skills required. Including: the ability to learn software applications such as the learning management system (LMS), document control, e-mail (Outlook), Sentry
  • DR/CAPA System, etc.
  • Must be able to cope with fast-paced operations and repeatedly perform multi-step simultaneous operations with a high degree of accuracy
  • Must be able to work under BC III (Class 100,000) gowning conditions
  • Must be able to lift up to ≤50 lbs. and push/pull up to 400 lbs. with assistance
  • Must be able to withstand frequent. repetitive movement, stooping, crouching, kneeling, climbing (ladders), and sitting
  • Must be able to work in cold rooms
  • Must not have unusual sensitivity to typical lab chemicals or gloves (i.e. sanitizing agents), use required chemicals, and wear protective clothing (PPE) and gowning as required
  • Must be able to differentiate color in order to monitor DCS computer and identify items using color-coded labels
  • Must meet Occupational Demands/Physical Requirement checklist
  • Blood test for Hepatitis B and vaccine required.
  • health care
  • vision
  • dental
  • retirement
  • PTO
  • sick leave
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