Multiple openings for over twenty (20) 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 April 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.
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
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.
Company Description
A great company doing groundbreaking and important work with a great reputation in the industry!
A great company doing groundbreaking and important work with a great reputation in the industry!
Seniority level
Entry level
Employment type
Full-time
Job function
Management and Manufacturing
Industries
Pharmaceutical Manufacturing
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