A leading biopharmaceutical company in Ireland is seeking an Associate Director of Manufacturing Support. This role involves leading manufacturing support teams, developing strategies to align with organizational goals, and ensuring compliance with regulatory requirements. The ideal candidate has over 8 years of experience in pharmaceutical manufacturing and strong leadership skills. This position also includes managing product lifecycle management and fostering collaboration across international teams. #J-18808-Ljbffr
Summary: Site lead for Contract Manufacturing Organizations (CMOs). Single point of accountability and interface between Amgen and assigned external partners. Responsibilities: Manufacturing operations: Develop and lead robust business processes, maintain reliable relationships with contract site management; assess industry trends, internal network, and technology advancements as tools to improve contract site performance. Manage budget development, monitoring, and reporting; create and manage contracts - confidentiality disclosure agreement(s), scope of work agreement(s), request for pricing/information, supply agreement(s) etc.; monitor and improve financials with CMO; actively manage and communicate forecasts to the sites and manage capacity planning. Drive operational excellence and champion change. Site performance monitoring: Manage contract site performance using lean tools and PDCA, lead site operating review meetings; drive improvements at contract sites; sustain and improve the overall health of the business, and lead communication/relationship with the contract site as well as internal management. Project Management and Technology transfer: Lead a department-wide project from conception to implementation and close-out. Present to and obtain buy-in for value proposition of such projects to senior management. Provide oversight of all planning and coordination of product transfer activities to the contract site(s); develop, present, and obtain approval of budget, timeline and ensure execution of transfer team activities to achieve seamless product transfer to the contract site(s); ensure risk management initiatives are taking place as per RM plan; lead site issue management and resolution; provide issue escalation to executive management. Qualifications: Minimum requirements (as per standard) Preferred Requirements: Bachelor's in Business Administration, Engineering, or Science-related field 5+ years of experience in DP, or packaging manufacturing environment 5+ years in roles requiring knowledge of cGMP principles, FDA and other regulatory guidelines, and validation principles 2+ years of experience working with external parties and/or leading cross-functional teams for clinical and/or commercial products 1+ years of project management experience leading multi-functional and multi-location team 1+ years of experience across ACDM Ability to travel +/- 20% of time (domestic and international) Location: Ireland Competencies: Demonstrated competencies of lower GCF levels. Demonstrated matrix management and influencing skills. Manufacturing and cGMP knowledge / experience. Demonstrated negotiation skills. Operational Excellence proficiency and ability to drive continuous improvement. Financial/budgeting knowledge and business acumen. Proficient project management skills. Problem-solving and critical thinking. Understanding of contractual requirements. Technical writing and multi-level communication skills. Demonstrated ability to lead effectively in collaborative/team environment. Demonstrated ability to take initiative, drive action, and work under minimum supervision. To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process, click the Apply button below to Login/Register.
Site Syringe Fill Finish Process Owner Job Summary: An exciting and rare opportunity has presented for a Site Fill Finish Process Lead at Amgen, Dublin. This is a senior role in the organisation and requires in-depth technical and operational knowledge of aseptic Drug Product manufacturing processes; Parts/Components Preparation, Formulation, Syringe Filling, Vial Filling, Lyophilisation and Capping. As a Fill Finish Process Lead you will be an established professional who is a self-starter, capable of applying advanced process knowledge and creativity to complete complex assignments related to the manufacturing operations. You are someone who contributes to the development of new principles and concepts, who wants to be challenged and can lead change from a manufacturing operations perspective. Supporting key areas of the business, the Fill Finish Process Lead will direct initiatives that improve the reliability and efficiency of manufacturing processes in addition to run the business support related to unplanned and/or disruptive events. Primary responsibilities: Perform as a knowledgeable subject matter expert (SME), and single point of contact on site and network projects and programs, to advance Fill Finish manufacturing operations Leading and/or providing input to strategic initiatives that will improve and develop processes for the future Contribute in a team environment to operational issues pertaining to processes as they arise and provide expertise and support to help resolve escalated technical issues as required Utilise subject matter expertise to identify and lead continuous improvement projects in assigned area of responsibility. Ensure project timelines are met, challenges identified, mitigations are in place and communication plans delivered to all stakeholders Involved in the daily business management systems and reporting, have a clear understanding of what is happening in the assigned area of responsibility. Monitor any process trends including business performance metrics. Identify actions that will enable the process and the Manufacturing areas better achieve and surpass metrics in the future Lead and/or Support investigations that impact on safety, quality and/or compliance of the processes, ensuring thorough investigations are carried out and actionable CAPAs, to prevent future reoccurrence, are identified and implemented within agreed timeline Remain current on state-of-the-art for systems and processes and advise on the appropriate adoption and use of new techniques and technology What you need to apply: Bachelor's degree in Science, Engineering or related discipline with 10 + years' experience in the pharmaceutical industry Experience with regulatory compliance in cGMP manufacturing and in-depth knowledge of Eudralex Volume 4, Annex 1 Manufacture of Sterile Medicinal Products. Proven ability to work in a high paced matrix organization and effectively influence change and escalate issues professionally and in a timely manner Excellent Decision-Making skills and confidence to respectfully and professionally challenge others on decisions that impact the manufacturing area Proactive and works well with others in a collaborative, fast-paced goal-driven environment Interacts well with diverse groups (Manufacturing, Validation, Engineering, Quality etc) and maintains strong working relationships with internal and external collaborators Demonstrated ability to coach, mentor and/or cross train colleagues within core technical areas Excellent verbal and written communication skills: Strong Technical writing skills for cGxP documentation (eg investigations, procedures, change controls) and good Presentation skills. To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process, click the Apply button below to Login/Register.
Overview: The Plant Quality Assurance (PQA) Snr Associate will report to the QA Manager and will be a core member of the site Quality Assurance team. The PQA Snr Associate will serve as Quality point of contact for manufacturing operations over seeing aseptic activities, performing area walks and complete AQL's on inspected drug product. The site is focused on continuous improvement of all work processes and practices, therefore in addition to routine Quality Assurance duties, PQA Snr Associates may be asked to carry out additional work functions to support site continuous improvement activities. This is a 24/7 shift role required to support manufacturing operations. Preferred Qualifications & Experience: Excellent written and verbal communication skills. Experience working with dynamic cross-functional teams and proven abilities in decision making. Strong organizational skills, including ability to follow assignments through to completion. Demonstrated ability in problem solving and experience in managing Non Conformance /Deviation investigations. Experience working in aseptic operations for vial and syringe filling. Experience or ability to perform AQL's on inspected drug product and to perform annual reserve inspections Knowledge of applicable Regulatory requirements, and ability to evaluate compliance issues. Key Responsibilities: Perform all activities in compliance with safety standards and SOPs. Write, review and approve Standard Operating Procedures in accordance with Policies. Provide Quality support for triage and investigation of all classes of non-conformance (NC) events. Review and approval of deviations for closure ensuring compliance with appropriate documentation, whilst ensuring that CAPA actions address root cause and implementation plan dates are achievable. Participates in customer complaint investigations. Provides training and advice to staff in order for them to perform their desired functions. Observe and provide real-time quality oversight, and support for production unit operations, extending to formulation, vial and Syringe Fill Finish related activities, including observation and provision of direction during media fills and assessment of aseptic interventions. Review/approve production batch records, and associated documentation in preparation for Qualified Person disposition activities. Review and approve cGMP records ensuring compliance with appropriate documentation. Support continuous improvement and Operational Excellence initiatives. Any other tasks/projects assigned as per manager's request. Basic Qualifications & Experience: University degree. Engineering or Science related discipline preferred. Relevant experience (4 yrs +) working in the pharmaceutical or biotechnology industry or other combination of experience and educational background that may otherwise satisfy the requirements of the role. Preferred Qualifications & Experience: Excellent written and verbal communication skills. Experience working with dynamic cross-functional teams and proven abilities in decision making. Strong organizational skills, including ability to follow assignments through to completion. Demonstrated ability in problem solving and experience in managing Root Cause Analysis /Deviation investigations. Experience working in aseptic operations, protein formulation, vial and syringe filling. Knowledge of applicable Regulatory requirements, and ability to evaluate compliance issues. To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process, click the Apply button below to Login/Register.
Job Summary: Reporting directly to the Associate EHS Director (for Expansion Projects), under minimal direction, manage all aspects of the development, implementation, and ongoing support of select ADL General Safety programs (including but not limited to Process Safety Management and related programs). Minimum Requirements: Degree in a Science/Engineering/EHS discipline with minimum 3 years' experience in associated roles, ideally in the pharmaceutical industry Ability to solve problems and provide solutions to a variety of complex safety problems. Self-driven with ability to work under minimal direction. People centered leader with high self-awareness and emotional intelligence Preferred Requirements: Qualification Mechanical Engineering / Process Safety or demonstrated knowledge of Utility and Process Systems. Some experience of managing direct reports. Some Environmental Compliance qualifications or experience. Strong knowledge of Irish and EU EHS legislation, standards, and design safety principles. Responsibilities (includes but are not limited to): Note - This role will initially be predominantly focused on Capital Expansion Project Support and will transition over time to an Operationally focused role. Support Capital Expansion Projects by: Participating in design reviews and providing technical EHS guidance on process safety, industrial hygiene, ergonomics, sustainability, and environmental controls. Support design risk assessments, HAZOPs, and constructability reviews to identify and mitigate EHS risks early in project lifecycle. Collaborate with engineering, facilities, and construction teams to ensure safe design and layout of new systems, utilities, laboratories, and manufacturing spaces. Drive implementation of sustainable design principles, including energy efficiency, waste minimization, and carbon reduction initiatives. Review and approve design documentation and equipment specifications from an EHS perspective. Support development of commissioning, qualification, and operational readiness plans with a focus on safe start-up and handover. Support Site Operations by: Implementing all assigned general Environmental, Health and Safety programs in compliance with all Regional regulations and Amgen requirements. Ensure all risks associated with these programs are assessed and documented with sufficient controls in place to ensure compliance and risks being managed. Partner with assigned functions to ensure a collaborative approach with key business clients, in particularly the Utilities Department. Ensure risk assessments are in place for all business partner activities and areas in scope and ensure appropriate change management processes are applied as appropriate. Ensure procedures are in place and training needs are identified for all relevant personnel on site, for those EHS programs in scope. Ensure documentation and investigation of any accidents, near misses and non-conformances in scope. Manage any directly reporting EHS team members at ADL and foster a continuous improvement mindset to ensure future growth and talent retention Track relevant performance metrics to ensure a data driven approach to identifying performance gaps and/or potential efficiencies Drive an Actively Caring culture through the site's consultation/engagement program and overall Total Workforce Health model. Competencies: 1. Ability to handle multiple projects at one time with good project and time management skills. 2. Strong communication skills both written and verbal. 3. Agile mindset with ability to adapt to changing program responsibilities if needed 4. Ability to deal successfully with various personalities and all levels of management. To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process, click the Apply button below to Login/Register.
ManufacturingSeniorAssociate - L4 Amgen Dun Laoghaire Live What you will do Let'sdo the world. As part of Amgen's Operations organization, Manufacturing continuously strives to be a differentiated leader in the manufacture of complex, high-quality therapeutics for our patients. The Senior Associate reportsto the Manager Manufacturing. The ideal candidate will provide strong leadership to the Manufacturing teams on a 24/7 shift pattern in a sterile Drug Product facility in fast paced and evolving environment. They will have strong GMP and quality system knowledge and the ability coach/mentor a team on the quality system requirements as well asmaintaininga strong culture of safety within their shift team and in the manufacturing area in general. The candidate will have excellent troubleshooting skills using standard industry problem solving techniques. Thesuccessful candidates willbe requiredto work a shift pattern. KeyResponsibilities: Support the Manufacturing Manager in leading a shift of Process Technicians to achieve production targets efficiently in line with GMP, safety and regulatory standards. Ensure shift Process Technicians are given clear direction and information to perform daily tasks as per the production schedule. Lead an assigned process area Work Centre Team (WCT) to ensure cross functional alignment onobjectivesand action plans. Maintainan accurate, up-to-date manufacturing schedule reflectingcurrent statusof production and plan critical path activities. Foster a good safety culture in our team and act as a safety role model. Oversee completion and review of documentation (batch records, EBRs) using relevant software systems and Standard Operating Procedures (SOPs). Proactivelyidentifytraining needsandfacilitatecompletion of training to meet the area resource and cross training models. Assist,planand implement continuous improvement initiatives using lean principles. Proactivelyidentifyand resolve process issues (including escalation and follow up) to minimize production disruptions. Supportandassistwith corporate, FDA, HPRA and other regulatory bodies during company audits. Lead on the 24/7 shift team in the absence of the Manufacturing Manager. Win What we expect of you Thesuccessful candidate for this role will bring the following education,skillsand experience Educated to pass Leaving Certificate standard or equivalent A third level qualification in a relevant subject area would be an advantage. Applicants should have relevant experience of operations of a manufacturing function in a sterile pharmaceutical manufacturing or similar environment. Aseptic experience preferred. Significant experiencein a GMP/other regulated environment. Demonstrated knowledge of GMP principles. Demonstrated aseptic knowledge in GMP areas. Drug product manufacturing experience. Experience working with equipmentutilizedin the manufacture of parenteral products such as autoclaves, fillinglinesand formulation vessels. Demonstrated ability to deliver to team,siteand personalobjectives. Demonstrated understanding and use of right first-time techniques and lean manufacturing concepts. Results-oriented. Excellent organizational, communicational and team development skills. Strong understanding of the quality system requirements and regulations for working in an aseptic drug product facility. Excellent communication skills. Team leadership experience (preferred). Excellentcomputer skills - knowledge of Electronic Batch Records, Quality Management Systems and Performance management Systems. Fluent Englishrequired. Thrive What you can expect of us In addition to the base salary, Amgen offers a Total Rewards Plan designed to support your health, financial wellbeing, work/life balance, and long-term career employee benefits package, including health and welfare plans for staff and eligible dependents,retirement andsavingsplan with generous company contributions, group medical,lifeand disability annual bonus learning, development, and career advancement opportunities,empowering employees to growand build long-term Amgen, we are committed to nurturing talent and providing meaningful pathways for professional development. Amgen is an equal opportunity employer. To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process, click the Apply button below to Login/Register.
Career Category Supply Chain Job Description Live What you will do Let’s do this. Let’s change the world. Amgen discovers, develops, and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realise the new science’s promise by bringing safe, effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people’s lives. The Supply Chain Specialist will hold primary responsibility for comprehensive management of ADL Supply Chain processes, encompassing Change Controls, Standard Operating Procedures (SOPs), oversight of departmental quality metrics, and resolution of supply chain deviations. The role demands a proactive approach to process governance and continuous improvement to uphold compliance and operational excellence. Supporting the day-to-day operation of complex automation systems at Amgen Dun Laoghaire (ADL) which is a 37,000 square metre aseptic drug product operations facility, specialising in secondary manufacturing activities – Formulation, Vial/Syringe Filling, Lyophilisation and Packaging. There is a strong culture of continuous improvement and innovation within ADL to strive for solutions that improve health outcomes and dramatically improve people’s lives. Amgen is developing the capability to produce all its medicines in Dun Laoghaire, helping to ensure continuity of supply of our medicines as we expand internationally. Key Responsibilities: Provide end to end project management of Supply Chain Change Controls (e.g. Supply Chain, External Warehouse, and Internal Warehouse changes) including generation of project timelines, critical milestones, identifying required resources from support functions, determination of critical path & appropriate sequence of task completion. Own, manage and resolve SC Major Deviations and some SC Minor Deviations , leading investigation teams in order to determine root cause, product impact potential, and Corrective & Preventative Actions (CAPA), and CAPA EVs. Providing support and technical mentorship to others in SC who own and manage Minor Deviations, CAPAs, CAPA EVs. Working closely with all SC sub-functions (Warehouse Operations, Warehouse Support, Master Data & Procurement, Short-Term Planning, Product Planning, and, Strategic Planning), Quality, Manufacturing, Inspection and Packaging. Writing Quality Risk Assessment Reports, and managing review and approval cycles with key stakeholders. Develop, review and update Supply Chain Standard Operating Procedures (SOPs) working with the relevant owners and SMEs. Develop protocols for execution in Supply Chain in support of change controls, deviations & troubleshooting investigations with support from relevant SMEs. Provide technical (Root Cause Analysis) RCA guidance to colleagues on EHS, quality and business processes. Trend analysis of quality system events relating to Supply Chain maintaining oversight of department milestones (CAPA’s, CAPA EVs, change controls and deviations). Assisting as needed in audits by external agencies in answering questions related to deviations and change controls. Engagement with global network Supply Chain leads along with local ADL resources as required. Assuring appropriate escalation to various levels of management if timeline requirements for deviation processing are exceeded. Performing other duties as the need arises by SC Management. Win What we expect of you The successful candidate for this role will bring the following education, skills and experience Bachelor's Degree in Science or Engineering and 5+ years of directly related experience in a biotech/pharma manufacturing or manufacturing support role (e.g. process development, engineering, quality, supply chain) or Associate's Degree in Science or Engineering and 8+ years of directly related experience in a biotech/pharma manufacturing or manufacturing support role (e.g. process development, engineering, quality, supply chain). Experience with investigations into quality deviations and determination of product impact potential, root cause, and corrective actions. Experience in running multiple, competing priorities in a fast-paced environment with Project Management experience. Strong technical writing and presentation skills. Ability to be flexible and manage change. Ability to communicate and collaborate with technical and management staff. Experience interacting with representatives of regulatory agencies. 6-Sigma / Lean Yellow Belt certification (Preferred). Proficient in viewing of SAP ERP (Preferred). Thrive What you can expect of us In addition to a competitive salary structure, Amgen offers a generous Total Rewards Plan for staff and eligible dependents. Comprehensive employee benefits package, including retirement and savings plan with generous company contributions, group medical, life and disability insurance. Discretionary annual bonus program. Exceptional learning, development and career advancement opportunities, empowering employees to grow and build long-term careers. At Amgen, we are committed to nurturing talent and providing meaningful pathways for professional development. #J-18808-Ljbffr
A global biotechnology company seeks a Supply Chain Specialist in Ireland to manage comprehensive supply chain processes and achieve operational excellence. The role involves overseeing change controls, leading investigations for deviations, and developing standard operating procedures. We look for candidates with a Bachelor's Degree and significant experience in biotech/pharma environments, as well as project management expertise. This position offers competitive compensation along with a robust benefits package. #J-18808-Ljbffr
Live Let's do this. Let's change the world. Amgen discovers, develops, and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realise the new science's promise by bringing safe, effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives. The Supply Chain Specialist will hold primary responsibility for comprehensive management of ADL Supply Chain processes, encompassing Change Controls, Standard Operating Procedures (SOPs), oversight of departmental quality metrics, and resolution of supply chain deviations. The role demands a proactive approach to process governance and continuous improvement to uphold compliance and operational excellence. Supporting the day‑to‑day operation of complex automation systems at Amgen Dun Laoghaire (ADL) which is a 37,000 square metre aseptic drug product operations facility, specialising in secondary manufacturing activities – Formulation, Vial/Syringe Filling, Lyophilisation and Packaging. There is a strong culture of continuous improvement and innovation within ADL to strive for solutions that improve health outcomes and dramatically improve people's lives. Amgen is developing the capability to produce all its medicines in Dun Laoghaire, helping to ensure continuity of supply of our medicines as we expand internationally. Key Responsibilities Provide end to end project management of Supply Chain Change Controls (e.g. Supply Chain, External Warehouse, and Internal Warehouse changes) including generation of project timelines, critical milestones, identifying required resources from support functions, determination of critical path & appropriate sequence of task completion. Own, manage and resolve SC Major Deviations and some SC Minor Deviations , leading investigation teams in order to determine root cause, product impact potential, and Corrective & Preventative Actions (CAPA), and CAPA EVs. Providing support and technical mentorship to others in SC who own and manage Minor Deviations, CAPAs, CAPA EVs. Working closely with all SC sub-functions (Warehouse Operations, Warehouse Support, Master Data & Procurement, Short‑Term Planning, Product Planning, and, Strategic Planning), Quality, Manufacturing, Inspection and Packaging. Writing Quality Risk Assessment Reports, and managing review and approval cycles with key stakeholders. Develop, review and update Supply Chain Standard Operating Procedures (SOPs) working with the relevant owners and SMEs. Develop protocols for execution in Supply Chain in support of change controls, deviations & troubleshooting investigations with support from relevant SMEs. Provide technical (Root Cause Analysis) RCA guidance to colleagues on EHS, quality and business processes. Trend analysis of quality system events relating to Supply Chain maintaining oversight of department milestones (CAPA's, CAPA EVs, change controls and deviations). Assisting as needed in audits by external agencies in answering questions related to deviations and change controls. Engagement with global network Supply Chain leads along with local ADL resources as required. Assuring appropriate escalation to various levels of management if timeline requirements for deviation processing are exceeded. Performing other duties as the need arises by SC Management. Win What we expect of you Bachelor's Degree in Science or Engineering and 5+ years of directly related experience in a biotech/pharma manufacturing or manufacturing support role (e.g. process development, engineering, quality, supply chain) or Associate's Degree in Science or Engineering and 8+ years of directly related experience in a biotech/pharma manufacturing or manufacturing support role (e.g. process development, engineering, quality, supply chain). Experience with investigations into quality deviations and determination of product impact potential, root cause, and corrective actions. Experience in running multiple, competing priorities in a fast‑paced environment with Project Management experience. Strong technical writing and presentation skills. Ability to be flexible and manage change. Ability to communicate and collaborate with technical and management staff. Experience interacting with representatives of regulatory agencies. 6‑Sigma / Lean Yellow Belt certification (Preferred). Proficient in viewing of SAP ERP (Preferred). Thrive What you can expect of us In addition to a competitive salary structure, Amgen offers a generous Total Rewards Plan for staff and eligible dependents. Comprehensive employee benefits package, including retirement and savings plan with generous company contributions, group medical, life and disability insurance. Discretionary annual bonus program. Exceptional learning, development and career advancement opportunities, empowering employees to grow and build long‑term careers. At Amgen, we are committed to nurturing talent and providing meaningful pathways for professional development. To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process, click the Apply button below to Login/Register. #J-18808-Ljbffr
A global biotechnology leader in Dún Laoghaire is seeking a Supply Chain Specialist to manage ADL Supply Chain processes and ensure compliance across operation functions. The ideal candidate will have significant experience in project management, technical writing, and quality assessment in the biotech or pharmaceutical sector. Strong mentorship abilities and collaboration with stakeholders are essential for success. The role offers a competitive salary and comprehensive benefits package in a dynamic environment focused on innovation. #J-18808-Ljbffr
