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Downstream Lead Manufacturing Associate (2nd Shift)
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- From our headquarters in Laupheim, Germany, and our site in Milford, MA, USA, we offer end-to-end solutions, including bioprocess development and manufacturing, as well as related consulting activities such as project management and regulatory support.
- Subject Matter Expert in cGMP downstream manufacturing; especially with Chromatography, Column Packing, Tangential Flow Filtration (TFF), Ultrafiltration/Diafiltration (UF/DF), Nanofiltration, Formulation, Bulk Drug Substance Aliquoting
- A thorough understanding of purification key performance indicators, column volumes, retention time, resin loading, linear velocity, TFF membrane loading, diafiltration factor, LMM and the science behind the downstream production of mAb's
- Specific equipment/systems that we are using include Cytiva Single Use Mixers (100L, 200L, 500L, 1000L), Cytiva AKTA Ready chromatography skid, Cytiva AKTA ReadyFlux XL TFF, TCU's, BSC's, Millipore and Sartocheck integrity testers, and disposable technology systems.
- Schedules daily activities for coworkers on shift, tracks completion of activities and reports on progress to manufacturing supervisor
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