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Biopharmaceutical Manufacturing Specialist
2 months ago
We are seeking a highly skilled Biopharmaceutical Manufacturing Technician to join our team at a multinational biopharmaceutical company in Berkeley, CA. As a key member of our production team, you will be responsible for the assembly and operation of cell culture bioreactor systems, including control of gas supply to bioreactors, micro-sparger assembly, and anti-foam emulsion systems.
Key Responsibilities:
- Assemble and operate cell culture bioreactor systems, including control of gas supply to bioreactors, micro-sparger assembly, and anti-foam emulsion systems.
- Prepare and operate continuous cells separation equipment, including process controls.
- Operate membrane absorption chromatography systems, including buffer and NaOH supply, cTCF supply, capsule preparation, inline dilution, and temperature controls.
- Perform basic knowledge of protein chemistry and purification systems, including anion, cation, and immunoaffinity chromatography.
- Operate membrane absorber technology, viral removal techniques, and tangential flow filtration technology.
- Perform daily or routine process operations in the cell culture and purification of biotech and biological products.
- Operate equipment for these processes, including inoculation and monitoring of bioreactors, processing of cTCF material to continuous cell separation, and operation of chromatography, MAEF, MAVF, and TFF skids.
- Perform aseptic operations, take and analyze samples, and monitor and control operations with computer control systems.
- Complete routine check sheets, clean equipment, and maintain clean and orderly production facilities.
- Perform in-depth troubleshooting and root cause analysis of equipment and process failures.
- Contribute to continuous improvement opportunities and perform other related duties as assigned.
Requirements:
- Two years of college science courses in biology, chemistry, biochemistry, or microbiology, or a certificate from an accredited bio-technology academy.
- BS in a 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.
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 bioreactors, micro-sparger assembly, and anti-foam emulsion systems.
- Continuous cells separation equipment preparation and process controls.
- Membrane absorption chromatography process, including buffer and NaOH supply, cTCF supply, capsule preparation, inline dilution, and temperature controls.
- Basic knowledge of protein chemistry and purification systems, including anion, cation, and immunoaffinity chromatography.
- Membrane absorber technology, viral removal techniques, and tangential flow filtration 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, including Delta V, Team, Outlook, and SAP.
- Experienced with Microsoft Office and excellent computer skills.
