22498052-Technical Services Specialist- Athlone Contractor

This role is on a 12 month contract with a view to extension.

Responsibilities

• Provide significant fill-finish technical expertise to support all aspects of the manufacturing of commercial and future late-stage clinical products at the Athlone Facility.

• Support technology transfers of new products into the Athlone Facility.

• Lead troubleshooting efforts and deviation investigations in conjunction with internal partners (Process Development, Manufacturing, Quality, etc.).

• SME for the introduction of single-use systems and assessment of their use in terms of extractable, leachable, 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 on 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 the 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 the manufacturing process operated in Athlone.

Requirements

• 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 in 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).