The Upstream Manufacturing Technician will be responsible for upstream unit operations such as seed expansion, bioreactor operations, cell culture harvest activities.
The Upstream Manufacturing Technician will have a working knowledge of upstream processing equipment : incubators, biosafety cabinets, bioreactors, cell counters, blood gas analyzers, metabolite testing equipment.
Additionally, the Upstream Manufacturing Technician will have knowledge of general bioprocessing equipment such as filters, filter integrity testers, balances, pumps, pH/conductivity meters, and disposable technologies (disposable bags, sterile tubing welders, tubing sealers).
Manufacture bulk intermediates and drug substances per manufacturing batch records and in compliance with quality standards, company policies and current regulations
Execute daily tasks and maintain strict accordance with manufacturing records, SOPs, and GMP
Perform operations in a cleanroom environment, applying controls to ensure aseptic processing including gowning and cleaning procedures
Document each task involving manufacturing records and logbooks following GDP at the time of execution
Review the executed production records and logbooks to ensure GxP compliance
Ensure all materials are issued and accounted for during the execution of a record (i.e. SR, EPR and BR)
Demonstrate and apply understanding of current Good Manufacturing Practices (cGMP) and how they apply to specific tasks and responsibilities
Participate and be accountable for room 5S
Utilize and perform maintenance on equipment per applicable SOP
Work individually or on teams to author standard operating procedures (SOPs) or Master Batch Records (MBRs); write corrective and preventive actions (CAPAs); and specify, commission, and qualify new equipment
Work cross-functionally with QA, MS&T, facilities, engineering, supply chain, IT, AFS, and other key departments to ensure startup and ongoing manufacturing operations are successful, reliable, and compliant
Bachelor’s degree in a related scientific or engineering discipline with 2-5 years’ experience in related GMP manufacturing operations; or high school diploma with 4-6 years’ experience in related GMP manufacturing operations
Working knowledge of Upstream operations is preferred
Experience in single-use platform technology is preferred
Excellent written and verbal communication skills are required
Energetic, motivated and dynamic individual
Organized and able to focus in a face-paced, multi-tasked environment and maintain operational efficiency and positive demeanor
Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists
Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form
Fluent in French
English level capabilities can be an asset
The job requires working on shifts which may include working overnight as well as week-end or “on duty” working periods.
Please note that due to the position's location, we can only consider candidates with European passports or Swiss working permits/citizenship.
Location: Switzerland - Plan-les-Ouates
KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.
Route de la Galaise 36, Plan-les-Ouates, Switzerland