Job details
The Technical Services MaterialsSpecialist has primary responsibility in supporting the cGMPmanufacture of biological bulk drug substance (BDS) at our clientsfacility in Blanchardstown, Dublin. The Technical ServicesMaterials Specialist will be responsible for providing support fornew material introduction to the Dublin facility, and will berequired to work in close collaboration with Technical ServicesTechnology Transfer Teams, Technical Services sustaining teams,Operations, Supply Chain, Quality, Quality Control and otherinvolved departments to ensure successful introduction andqualification of new materials. Theposition is accountable for leading NMI workstreams to supportprojects and sustaining manufacturing and providing NMI expertiseto support other functionalgroups.You will be responsiblefor:To provide process expertisein:Materials:Acting as technical SME to support the selection and introductionof critical raw materials and single use components Providingtechnical leadership for material/component related issues,complaints, and investigations Liaising with Vendors to ensure theyconduct adequate investigations and implement appropriatecorrective actions when issues areidentifiedTosupport the introduction of new raw materials and consumablesthrough the generation of materials lists, Bills of Materials,material specifications and outline testing requirements To workclosely with colleagues in Quality, Supply Chain and ManufacturingOperations to ensure availability and release of materials to meettechnology transfer and routine manufacturing timelines Lead anykey process changes using change control system Adherence tohighest standards for Compliance (Quality and Safety), implementcorporate standards and liaise effectively with global groups andprovide technical support during audits Ensure compliance with siteEHS policy, cGMP and other business regulations and participate inrisk assessments, audits, and incident investigations To serve as asubject-matter expert (SME) on NMI and process support duringregulatory agencyinspectionsRequirementsSkills:Experiencein Technical Services / Process Development / Manufacturing in abiological bulk drug substance manufacturing organization Technicaland operational knowledge of multiple unit operations in drugsubstance manufacturing Comprehensive understanding of cGMPrequirements for biopharmaceutical manufacturing Good interpersonalskills coupled with demonstrated ability to effectively work in amatrix organization, and in local group settings Ability to presentand defend technical and scientific approaches in both written andverbal form Ability to drive for results independently and adapt torapidly changing priorities Experience of Technology Transferactivities is advantageous Detail orientated Technical writingcompetencySkills: Experience in Technical Services / Process Development /Manufacturing in a biological bulk drug substance manufacturingorganization Technical and operational knowledge of multiple unitoperations in drug substance manufacturing Comprehensiveunderstanding of cGMP requirements for biopharmaceuticalmanufacturing Good interpersonal skills coupled with demonstratedability to effectively work in a matrix organization, and in localgroup settings Ability to present and defend technical andscientific approaches in both written and verbal form Ability todrive for results independently and adapt to rapidly changingpriorities Experience of Technology Transfer activities isadvantageous Detail orientated Technical writingcompetency
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