Technical Services Specialist
PE Global is currently recruiting for a Technical Services Specialist on behalf of our client based in Athlone. This is an initial 12-month contract role.
- Provide significant technical expertise to support all aspects of the mammalian bulk drug substance cell culture and purification manufacturing.
- Process SME to support commissioning, automation and manufacturing operation teams.
- 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.
- To author and review process supporting documentation, process descriptions, gap assessments, technical protocols and reports, process validation documentation, strategy documents.
- To support the introduction of new raw materials and consumables through the generation of materials lists, Bills of Material updates, material specifications.
- To work closely with colleagues in Quality, Supply Chain and Manufacturing Operations to ensure availability and release of materials to meet technology transfer and routine manufacturing timelines.
- Technical review of change controls for impact to product quality, safety and efficacy.
- Provide on-floor technical support and troubleshooting.
- Partner with Operations to support protocol completion, execution and sample reconciliation.
- To generate documentation reports for technical studies
- Lead any key process changes using change control management system as required.
- Adherence to highest standards for Compliance (Quality and Safety), implement corporate standards and liaise effectively with global groups and provide technical support during audits.
Education and Experience:
- Minimum BS degree in Scientific (Biochemistry, Biology, Chemistry) or Engineering (Chemical, Mechanical) related field.
- Experience in technical services support in the manufacture of mammalian drug substance cell culture and purification and/or process development and/or manufacturing support
- Experienced in relevant unit operations including vial thaw and scale up, seed train and production bioreactors, harvest, chromatography, UF/DF, viral filtration and inactivation, final formulation and media and buffer preparations.
- Experience of technology transfers and implementing new clinical and commercial biopharmaceutical manufacturing processes, specifically in the manufacture of mammalian bulk drug substance operations.
- Prior experience of single use systems (bioreactors, single use mixers) would be an advantage
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