Upstream Manufacturing Lead

Position OverviewThe Manufacturing Technician IV will work directly with a range of technologies.

The Technician IV level provides an opportunity to stay on the technical track or work towards a supervisory path.

Dependent upon assignment, the range of technologies may include any of the following : Job DescriptionUpstream 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 Fiber Tangential Flow Filtration (HFTFF), Nanofiltration and depth filtrationMedium to Large-scale Chromatographic systems (ÄKTA).

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 all other duties as assigned.Technician IV Minimum Qualifications : Bachelors degree in Biology, Microbiology, Chemistry, Biochemistry, Engineering or related field and 2 years of relevant experience; ORAssociates degree in Biology, Microbiology, Chemistry, Biochemistry, Engineering or related field and 4 years of relevant experience; ORHigh School / GED with 6 years of relevant experience.Join us!

FDB is advancing tomorrow's medicine, impassioning employees to chase the impossible and continually expand their potential.

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