Position Summary
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….
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