This is a 6 month contract role.
• Provide significant technical expertise to support all aspects of the manufacturing of commercial and cell culture derived biopharmaceutical products at CMOs.
• Lead troubleshooting efforts and high-level deviation investigations in conjunction with CMOs and internal partners (Process Development, Manufacturing, and Quality.)
• Support all aspects of the manufacturing process from cell culture through downstream processing, testing and release.
• Technical review of change controls for impact to product quality, safety and efficacy.
• Provide on-floor technical support and troubleshooting at the CMO facility.
• Identify and then lead process optimization initiatives and address opportunities for efficiency and capacity improvements in all areas of manufacturing.
• Technical protocol and summary report generation as related to technical studies executed in direct support of GMP manufacturing activities.
• Collection, organisation, trending, and analysis of GMP manufacturing data.
• Identify manufacturing best practices across the network and lead or participate in teams to implement best practices.
• Provide SME input for IND, BLA and other technical documents for regulatory agency submission in support of manufacturing process operated at CMOs.
• Up to 20% international travel may be required.
• Minimum BS degree in Scientific (Biochemistry, Biology, Chemistry) or Engineering (Chemical, Mechanical) related field.
• Minimum 1-3 years’ experience in providing technical support to biologics drug substance manufacturing.
• Knowledge of mammalian cell culture and purification unit operations.
• Comprehensive understanding of cGMP requirements for biopharmaceutical manufacturing and the ability to implement best practices.
• Experience of working with CMOs would be a distinct advantage, demonstrating strong communication and influencing skills.
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