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KBI: US - Lead Manufacturing Associate
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$42.31 - $58.17 an hour
Full-time
- The lead manufacturing associate is responsible for performing upstream or downstream processing of bulk intermediates and/or bulk drug substances for biopharmaceutical products.
- The lead manufacturing associate must follow written, approved procedures and forms to ensure all work is conducted “Right First Time” (RFT) following Good Manufacturing Practices (GMP), including good documentation practices (GDP), and/or Good Laboratory Practices (GLP).
- As needed, the lead manufacturing associate will 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.
- The lead manufacturing associate will be responsible for upstream unit operations (seed expansion, bioreactor operations, cell culture harvest), downstream unit operations (chromatography, tangential flow filtration, viral inactivation, and bulk filling) and/or manufacturing support operations (solution preparation, assembly preparation, parts wash, and autoclave) activities.
- The lead manufacturing associate will have past experience and a working knowledge of upstream processing equipment, downstream processing equipment, and/or manufacturing support equipment.
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