This is a 12 month contract position.
• Provide significant fill-finish technical expertise to support all aspects of the manufacturing of commercial and future late stage clinical products at the Facility.
• Support technology transfers of new products into the Facility.
• Lead troubleshooting efforts and deviation investigations in conjunction with internal partners (Process Development, Manufacturing, and Quality etc.)
• SME for introduction of single use systems and assessment of their use in terms of extractables, leachables and container closure.
• Support all aspects of the manufacturing process from raw material selection and specification through formulation and filling to visual inspection, testing and release.
• Technical review of change controls for impact to product quality, safety and efficacy.
• Provide on-floor technical support and troubleshooting.
• 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.
• Support establishment of validation plans and evaluation of drug substance/product production site options.
• Provide SME input for IND, BLA and other technical documents for regulatory agency submission in support of manufacturing process operated in the facility.
• Minimum BS degree in Scientific (Biochemistry, Biology, Chemistry) or Engineering (Chemical, Mechanical) related field.
• Experience in fill-finish process development and/or manufacturing support with extensive practical knowledge of liquid fill operations.
• Experienced in relevant unit operations including mixing, formulation, sterile filtration, sterilisation, aseptic processing, component processing technologies, liquid filling and visual inspection.
• Comprehensive understanding of cGMP requirements for clinical and commercial biopharmaceutical manufacturing and the ability to implement best practices.
• Experience of technology transfers and implementing new clinical and commercial biopharmaceutical manufacturing processes, specifically sterile liquid fill operations.
• Ability to present and defend technical aspects of manufacturing operations during regulatory agency inspections.
• Familiarity with protein handling and processing considerations and how operating conditions can impact Critical Quality Attributes (CQA.)
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