Upstream Unit:Single-Use Cell Culture Vessels/Bioreactors up to 2000LBacterial Fermentation Culture Vessels up to 2000LAlpha Wasserman Continuous Flow CentrifugesDisposable Magnetic Mixing Bags and TotesCell Expansion and PropagationBanking/Cryopreservation of Cell Lines and VirusesHyperstack, Cellstack, and other Adherent Cell TechnologiesPlate counting, microscopic examinationMonitor cultures, take samples, turn-around of bioreactor and fermenters, sterilization, and inoculationDownstream Unit:Medium to Large-scale filtration systems including Tangential Flow Filtration (TFF), Hollow FiberTangential Flow Filtration (HFTFF), Nanofiltration and depth filtrationMedium to Large-scale Chromatographic systems(AKTA).Pre-Packed Columns from 1L to 100LSingle use mixing systems (Pall &GE)Single Use connectivity types such as GE DAC and Colder AseptiQuikBulk fillingAseptic process simulation and drug product fillingPlate counting, microscopic examinationMonitor cultures, take samples, turn-around of bioreactor and fermenters, sterilization, and inoculationBuffer Preparation Unit:Preparation of medium from stock raw materials including the compounding, mixing, testing and filtration for further process needsPreparation of buffers from stock raw materials including the compounding, mixing, testing and filtration for further process needsWeighing of raw materials per batch record specifications and assignment of appropriate expiry per proceduresIntegrity testing of filtersEssential Functions Include:Write and review standard operating procedures, buffer formulation records and batch production records.Assist senior staff in implementing project safety and quality assurance programs in accordance with SOPs.Maintain the confidentiality of proprietary company information.Document and maintain activity records according to cGMP regulations and ensure junior team members are trained.Operate general production equipment such as Autoclaves, Glass washers, Incubators, Analytical Scales, pH/conductivity meters, etc.Perform daily cleaning and sanitization of the laboratory and manufacturing areas.Maintain an effective working relationship with others.Perform all other duties as assigned.
1-4 years
Experience in a GMP environment Biotechnology Certificate
Excellent oral and written communication skills, interpersonal and organizational skills.Proficient with Microsoft Office applications.Excellent leadership skills.Ability to train others to perform to cGMP standards.Good self-discipline and attention to detail.Must be able to work flexible work hours, and be willing to work outside of normal, scheduled hours; as necessary.Must be able to work alternative shift hours and weekends as required.Excellent math and computer skills.Experience working in a cleanroom environment with full clean room gowning and good aseptic technique.Must have good planning and time management skills and be willing and able to interface with colleagues in manydifferent roles and functions throughout the manufacturing facilities.
High School
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