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 inoculating and monitoring 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 formulates 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: Cell Culture bioreactor system assembly and use, Continuous cell separation equipment preparation and process/controls, Membrane Absorption Chromatography process, Basic knowledge of protein chemistry and purification systems.
Familiarity with cGMP's and applicable agency regulations.
Good verbal and written communication skills.
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.