As a pilot production associate in the Clinical production team within Biopharmaceutical Development, you’ll build broad knowledge of bioprocessing in a cGMP environment to launch your career in the biopharmaceutical industry. In this role you will take an adaptable, science driven approach to everything you do. You will become an integral part of process development, accelerating product candidates into the clinic and gaining knowledge and experience in cell culture, purification and critical support activities. Under the supervision of highly trained personnel, you will gain the process knowledge and skillsets to perform large scale clinical development activities through hands-on training. You will join a collaborative and driven team in a world class biopharmaceutical company that is driving disruptive innovation in the industry.
Bachelors degree and 0+ years experience OR Associates degree and 1-2 years experience OR high school diploma and 5+ years experience.
- Operates bio-pharmaceutical manufacturing equipment such as: incubators, stainless steel and disposable single-use bioreactors, depth filtration skids, LN2 dewars, chromatography skids, single-use mixers, centrifuges, washers, autoclaves, tanks and in-process testing instruments.
- Performs SIP, CIP and manual cleaning and sanitization of equipment
- Monitors critical process parameters and troubleshoots equipment during processing.
- Performs daily manufacturing tasks per Standard Operating Procedures and Manufacturing Production Records.
- Documents all manufacturing activities clearly and accurately per cGMP and regulatory requirements.
- Prepares for processing by ensuring equipment and materials necessary are adequate and available.
- Ensures all production activities are completed in an aseptic, safe and compliant manor.
- Interacts regularly with co-workers, senior personnel and supervisors in dynamic team environment to improve quality and process efficiency
Purification Technical Principal Duties
- Introductory knowledge of Column Chromatography process operations, column packing TFF (Tangential Filtration Flow) and basic analytical testing (e.g. Protein concentration, osmolarity, pH etc.)
Cell Culture Technical Principal Duties
- Prepare stainless steel and disposable bioreactors and tanks to include Pressure Test, CIP, SIP, and Centrifuge Harvest
- Perform aseptic technique and cell banks operations
- Prepare and charge the LN2 dewar for vial shipment
Support Services Technical Principal Duties
- Preparation and filtration of production scale buffer and media solutions.
- Operate area specific production equipment such as glass washers, autoclaves, fixed and portable stainless steel tanks, etc.
- Weighs and checks raw materials, assembles and cleans process equipment, monitors processes