Technical Services Specialist
The contract duration is 12 months and 40 hours per week.
Located 15 minutes from Dublin Airport and just a short distance from the lively, vibrant, and cultural Irish capital, this leading biopharmaceutical organisation leads the way with state of the art technology on their one of a kind manufacturing facility.
The Senior Specialist Technical Services has primary responsibility for providing technical support of commercial and clinical drug product manufacturing operations performed at contract manufacturing organisations (CMOs).
Key Responsibilities for the Technical Services Specialist:
- Provide significant fill-finish technical expertise to support all aspects of the manufacturing of commercial and late stage clinical products at CMOs.
- Lead troubleshooting efforts and high-level deviation investigations in conjunction with contractors and internal partners (Process Development, Manufacturing, and Quality).
- 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 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.
- Support establishment of validation plans and evaluation of drug product production site options
- Provide SME input for IND, BLA and other technical documents for regulatory agency submission in support of manufacturing process operated at CMOs.
- Up to 25% international travel required.
Please apply now for more information:
Direct number: 01442 860 525.
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