What are the responsibilities and job description for the Bioprocess Manufacturing Technician - 3rd shift openings! position at Randstad Life Sciences US?
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 :
Preferred Skills and Experience :