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ESSENTIAL DUTIES
• Perform routine manufacturing operations related to Downstream Manufacturing such as column chromatography, viral inactivation, viral reduction filtration, UF/DF, bulk drug substance fill, and cleaning and disinfection of materials and equipment.
• Set up, operate, and maintain complex manufacturing equipment such as AKTA Process Skids, TFF Skids, mixers, balances, autoclaves, and parts washers.
• Lead and train junior associates in manufacturing processes and activities.
• Perform all work in a compliant manner in alignment with current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP).
• Draft, revise, and follow Standard Operating Procedures (SOP’s) and batch records using good documentation practices.
• Identify opportunities for continuous improvement and improved quality compliance.
• Support area management in deviation investigations, change controls, validation protocols, and other activities as needed.
• Collaborate within assigned team and other stakeholders to build a positive and high performing collaborative culture.
MINIMUM REQUIREMENTS
• BS in science or a related field and 3+ years relevant experience in pharmaceutical manufacturing OR 6 + years relevant experience in a pharmaceutical manufacturing environment.
• 3+ years direct experience in biologics manufacturing.
PREFERRED REQUIREMENTS
• Experience in upstream, media and buffer preparation, and/or aseptic fill/finish processing operations
• Experience leading a team or in a supervisory role (formal or informal)
• Experience writing SOP’s, batch records, change controls, and/or deviation investigations.
• Experience or training in Lean Sigma principles and continuous improvement and/or Leadership.
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