12 Month Contract - Highly RemoteNOTE: The successful candidate is required to be located within Rep. of Ireland.Sr Associate Contract Development & ManufacturingThe Sr Associate Contract Development & Manufacturing at Amgen provides technicalsupport to the External Supply manufacturing team, solves complex production problems,and implements improvements to enhance efficiency and quality.Working within the diverse Commercialisation & Performance Execution (CPE) team, thisrole works in partnership with different departments & stakeholders to ensure a smoothmanufacturing process and compliance with quality standards.The role helps provide information insights and data analysis; identify problems and troubleshoot to evaluateoptions and solutions; drive precision through the execution of transactional/tactical tasks toensure Amgen Contract & Development Manufacturing (ACDM) work cell (hub) success.The role also requires applying process, operational, and scientific expertise, as well asbasic compliance knowledge and analytical and troubleshooting abilities, to support qualityrecords originating from manufacturing sites throughout Amgen's External Supply network.Additionally, the role provides a strategic dimension to the External Supply manufacturingnetwork to improve operational competitiveness and ensure uninterrupted global supply ofmedicines to our patients - Every Patient, Every Time.ResponsibilitiesManufacturing Operations: The successful candidate is expected to own and executevarious quality record types, including Deviations (Major/Minor), CAPA, SICAR, ChangeControl and perform metrics oversight responsibilities. Liaise with Third Party CDMOs tomaintain and monitor systems to ensure all record received are appropriately investigatedand concluded per Amgen's quality standards and procedures. Support/Lead investigationteams to identify meaningful root causes and robust corrective and preventative actions byeffectively utilizing advanced root cause analysis tools. Optimise deviation management,corrective and preventive actions effectiveness to prevent reoccurring events.Site Performance Monitoring: Report Third Party CDMO site performance metrics to sitelead; identify improvement opportunities for site performanceDaily duties will include: coordination, issuance, and review of meeting minutes, conclusions from analysis of data and metrics, continuous improvement and standardisation of performance tools used by theWork Centre Teams (WCT), oversight and reporting of procurement/payment of invoices,and active participation in WCT meetings with the contract site as well as internal site teamTeamwork: Facilitation of cross-functional teams (internal and external to External Supply).Work closely with the suppliers and External Supply peers to address and close criticalinvestigations and Corrective Actions. Participate in the assessment or implementation ofcontinuous improvement projects or initiatives. Communicate with all levels of theorganization, facilitate development of solutions to critical business issues, and effectivelydefine objectives to enable effective metric generation and reporting.What we expect of youThe successful candidate for this role will bring the following education, skills andexperience.Preferred Requirements: Master's Degree (L9) in Business Administration, Engineering or Science-related field Bachelor's Degree (L8) in Business Administration, Engineering or Science-related field,with 2+ years of experience in GMP protein, API, DS, DP or packaging manufacturingenvironment Ordinary Bachelor's Degree or lower (L7 or lower) in Business Administration,Engineering or Science-related field, with 5+ years of experience in GMP protein, API,DS, DP or packaging manufacturing environment Experience in roles requiring knowledge of cGMP principles, FDA and other regulatoryagency guidelines, and validation principles Understanding of applicable manufacturing/testing processes (i.e. protein, API, DrugSubstance, Drug Product, Packaging, Device manufacturing processes)Preferred Competencies: Strong technical background with understanding of pharmaceutical manufacturing,commercialisation, and cGMP knowledge / experience. Problem-solving, critical thinking and decision-making skills. Demonstrated negotiation skills, accountability to deliver results and meet deadlineswhile handling contending priorities. Technical writing and multi-level communication skills. Demonstrated ability to perform effectively in a collaborative/team environment. Demonstrated ability to take initiative, drive action, and work under minimumsupervision. Proficiency in Microsoft Office especially Project, Excel, PowerPoint, Visio, andSmartsheet Demonstrated experience with QMS and Digital tools including Veeva Vault,TrackWise, AI software. Experience with supporting/managing Third Party CDMO sites
