Senior Associate Manufacturing

2 weeks ago

Dublin, Dublin City, Ireland Amgen Full time

Job Summary: The Sr. Associate Manufacturing - Strategic Projects role offers the opportunity to collaborate with multiple functions within the Amgen Dun Laoghaire site on a routine basis in a dynamic environment (Quality Assurance, Quality Control, Engineering, Facilities, Maintenance, Process Development, Process Engineering, etc.) while developing a deep understanding of the manufacturing operations and planning activities within the facility. The Operations Lead will serve as primary production process owner responsible for New Product Introduction, Life Cycle Management Projects and/or CAPEx projects and established process improvements projects. This role requires in-depth technical and operational knowledge of aseptic Drug Product manufacturing processes; Parts/Components Preparation, Formulation, Syringe Filling, Vial Filling, Lyophilisation and Capping. They will be the operations point of contact for coordination of the manufacturing effort and will be responsible for driving process efficiencies as part of the project for operations. They will apply process, operational, scientific expertise, basic compliance knowledge, and analytical and troubleshooting skills to ensure streamlined manufacturing operations are enabled in both vial and syringe facilities. This role is primarily based on-site at Amgen Dun Laoghaire. Primary Responsibilities: Function as the site interface between the Product Delivery Teams (PDT's), and ADL Manufacturing operations. Engaging with staff members within the Manufacturing department to ensure understanding of the processes and working collaboratively cross-functionally with Facilities & Engineering, Quality, PD and Supply Chain. Develop, review, and approve Generic Master Batch Records and Parameter Value Lists across Formulation, Filling and Inspection Develop, review and update Production, Engineering, Operating Procedures & training materials Assist in providing training on scientific or technical aspects of the current process/project(s) to Direct Manufacturing Evaluate, plan, and implement solutions for process improvement opportunities both current and project related. Support scheduling and execution of Characterisation, Engineering and PPQ runs, ensuring all necessary pre-requisites are included on the schedule and assess process performance by observation of floor operations and review of performance data Provide troubleshooting support throughout the project and on the floor during execution of activities Hold people to account for delivery and behaviours within the Manufacturing Support team and associated with the project(s) Perform Job Hazard Assessments and Change Control Assessments to determine impact to Manufacturing Partner with Learning & Performance to define training strategies for current processes, NPIs and complex projects Consult with Quality Assurance to ensure that GMP standards are maintained in line with current SOP's, batch documentation and licences Develop, review and update protocols for manufacturing activities Documentation and approval of protocol deviations for manufacturing activities Consult with Process Development, Direct manufacturing, Equipment, and System Owners regarding process changes in an effective and timely manner Own and lead change controls as required by the Manufacturing Support team Review Bills of Materials Develop, review and update Product Quality Risk Assessments Knowledge/Skills: Strong project management and organisational skills, including ability to follow assignments through to completion Critical thinking skills: Gathers data from key stakeholders, analyses and interprets information to develop solutions to technical problems of moderate complexity Negotiation and Influencing skills Take initiative to identify and drive improvements Excellent verbal and written communication skills: Strong technical writing skills for GMP documentation (e.g., investigations, procedures, change controls) and good presentation skills Escalate issues professionally and in a timely manner Decision Making skills and confidence to challenge others on decisions that impact the manufacturing area Teamwork and coaching others Ensures compliance within regulatory environment Demonstrated ability to work independently and deliver right first-time results under minimal direction Relevant Experience: Bachelor's degree in a science discipline. 5+ years of biopharmaceutical manufacturing experience in Fill Finish or related manufacturing or GMP experience in the pharmaceutical or medical device industry. Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products. 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.

  • Senior Associate Manufacturing

    1 week ago

    Dublin, Dublin City, Ireland Amgen Inc. (IR) Full time

    Senior Associate Manufacturing page is loadedSenior Associate ManufacturingApply remote type On Site locations Ireland - Dun Laoghaire time type Full time posted on Posted 2 Days Ago job requisition id R-209747Career CategoryManufacturingJob DescriptionJob Summary:The Sr. Associate Manufacturing – Strategic Projects role offers the opportunity to...

  • Senior Manufacturing Bioprocess Associate

    3 weeks ago

    Dublin, Dublin City, Ireland Planet Pharma Full time

    Senior Manufacturing Bioprocess AssociateAs a Senior Manufacturing Bioprocess Associate, you will be a key player in end-to-end production operations within a flexible, multi-product manufacturing environment. You'll work with both Fed-Batch and Continuous Manufacturing processes and collaborate within a dynamic team to ensure smooth and efficient...

  • Senior Manufacturing Bioprocess Associate

    1 week ago

    Dublin, Dublin City, Ireland Planet Pharma Full time

    Senior Manufacturing Bioprocess AssociateAs a Senior Manufacturing Bioprocess Associate, you will be a key player in end-to-end production operations within a flexible, multi-product manufacturing environment. You'll work with both Fed-Batch and Continuous Manufacturing processes and collaborate within a dynamic team to ensure smooth and efficient...

  • Senior Manufacturing Bioprocess Associate

    2 weeks ago

    Dublin, Dublin City, Ireland PSC Biotech Corporation Full time

    Senior Manufacturing Bioprocess AssociateIndustry: Pharma/Biotech/Clinical ResearchWork Experience: 1-3 yearsCity: MeathState/Province: MeathCountry: IrelandJob DescriptionAbout PSC BiotechPSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with global operations in Ireland, India, Singapore,...

  • Senior Manufacturing Bioprocess Associate

    2 weeks ago

    Dublin, Dublin City, Ireland PSC Biotech Full time

    Senior Manufacturing Bioprocess AssociateIndustry: Pharma/Biotech/Clinical ResearchWork Experience: 1-3 yearsCity: MeathState/Province: MeathCountry: IrelandJob DescriptionAbout PSC BiotechPSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with global operations in Ireland, India, Singapore,...

  • Manufacturing Associate

    4 days ago

    Dublin, Dublin City, Ireland Russell Tobin Full time

    What are we looking for in our Manufacturing Associate ?Exciting Job OpportunityManufacturing Process AssociateRussell Tobin collaborates with a prominent global biologics manufacturer, known for its dedication to enhancing the well-being of patients and staff.They hold the prestigious title of being one of Ireland's top large workplaces, and their...

  • Manufacturing Associate

    1 week ago

    Dublin, Dublin City, Ireland TN Ireland Full time

    Social network you want to login/join with:What are we looking for in our Manufacturing Associate?Exciting Job Opportunity Manufacturing Process AssociateRussell Tobin collaborates with a prominent global biologics manufacturer, known for its dedication to enhancing the well-being of patients and staff. They hold the prestigious title of being one of...

  • Senior Associate Manufacturing

    2 weeks ago

    Dublin, Dublin City, Ireland Amgen Full time

    Location field must contain 'city, state' or a zip code to perform a radius search (e.g., Denver, CO or 46122 ). City and state must be separated by a comma followed by a space (e.g., Houston, TX )Job Summary:The Sr. Associate Manufacturing – Strategic Projects role offers the opportunity to collaborate with multiple functions within the Amgen Dun...

  • Manufacturing Process Associate

    2 days ago

    Dublin, Dublin City, Ireland Psc Biotech Ltd Full time

    Job Title: Bioprocess AssociateRole Description:A fantastic opportunity has arisen for a Bioprocess Associate responsible for procedures and processes associated with large-scale drug substance manufacture at the manufacturing facility.The successful candidate will be responsible for equipment preparation, operation, monitoring, use of business systems and...

  • Commercial Manufacturing Associate

    1 day ago

    Dublin, Dublin City, Ireland PSC Biotech Corporation Full time

    Job OverviewA fantastic opportunity has arisen for a Bioprocess Associate to join our team. You will be responsible for procedures and processes associated with commercial large-scale drug substance manufacture at our manufacturing facility. The role involves preparation, operation, and monitoring of equipment, use of business systems, and carrying out tasks...

  • Production Manufacturing Associate

    6 days ago

    Dublin, Dublin City, Ireland Life Science Recruitment Full time

    LIFE SCIENCE RECRUITMENT IS SEEKING A HIGHLY SKILLED PRODUCTION MANUFACTURING ASSOCIATE TO JOIN THEIR TEAM IN MEATH. AS A PRODUCTION MANUFACTURING ASSOCIATE, YOU WILL PLAY A KEY ROLE IN THE SMOOTH OPERATION OF THE MANUFACTURING FACILITY, WORKING CLOSELY WITH THE MANUFACTURING OPERATIONS GROUP, PROJECT DESIGN TEAM, AND CQV TEAM TO DEVELOP AND VALIDATE THE...

  • Manufacturing Bioprocess Associate

    1 day ago

    Dublin, Dublin City, Ireland PSC Biotech Corporation Full time

    About PSC BiotechWho are we?PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with global operations in Ireland, India, Singapore, Australia, and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory...

  • Senior Associate Manufacturing Specialist

    7 days ago

    Dublin, Dublin City, Ireland Amgen SA Full time

    About the RoleWe are seeking a highly skilled Sr. Associate Manufacturing Specialist to join our team at Amgen SA. As a key member of our operations team, you will play a critical role in ensuring the smooth execution of manufacturing processes and projects.Responsibilities:Function as the site interface between product delivery teams and ADL manufacturing...

  • Manufacturing Associate

    1 day ago

    Dublin, Dublin City, Ireland SRG Full time

    Key ResponsibilitiesIn this role as a Manufacturing Associate, you will be responsible for assembling and testing products in accordance with company procedures and drawings.You will also be required to maintain accurate records, achieve weekly targets through effective teamwork, and ensure that work areas and equipment are maintained in accordance with...

  • Manufacturing Bioprocess Associate

    2 weeks ago

    Dublin, Dublin City, Ireland QCS Staffing Full time

    Manufacturing Bioprocess Associate - Dublin, Ireland - 11 Months ContractThis is a fantastic opportunity to be part of a fast-paced, €400 million project; with lots of opportunities to work with and learn about cutting-edge technologies, in addition to developing your own skills.This is a truly exciting project, which when complete will contribute to the...

  • Manufacturing Compliance Associate

    1 day ago

    Dublin, Dublin City, Ireland Life Science Recruitment Full time

    Our MissionWe are committed to delivering outstanding results through our expertise in life sciences recruitment. Our mission is to provide innovative solutions that connect talented professionals with exciting opportunities in the pharmaceutical industry.Job OverviewThis is an excellent opportunity to join a multinational pharmaceutical organization based...

  • GMP Manufacturing Associate

    3 hours ago

    Dublin, Dublin City, Ireland Life Science Consultants (LSC) Full time

    We are seeking a skilled GMP Manufacturing Associate to join our team in Dublin. In this role, you will work closely with cross-functional teams to implement process improvements, support new product introductions, and transfer technologies.Your responsibilities will include representing manufacturing at meetings, identifying process improvement projects,...

  • Strategic Projects Senior Associate Manufacturing

    6 days ago

    Dublin, Dublin City, Ireland Amgen SA Full time

    Job Description:">The Sr. Associate Manufacturing – Strategic Projects role offers an exciting opportunity to work in a dynamic environment, collaborating with multiple functions within the Amgen Dun Laoghaire site. This position requires in-depth technical and operational knowledge of aseptic Drug Product manufacturing processes, including...

  • Manufacturing Quality Associate

    1 week ago

    Dublin, Dublin City, Ireland Life Science Recruitment Full time

    Your Career OpportunityAs a QA Associate Specialist at our client's site, you will be part of a dynamic team dedicated to delivering high-quality products. With a focus on regulatory compliance and quality assurance, you will play a critical role in maintaining and improving processes to ensure seamless manufacturing operations.About the RoleWe're looking...

  • Senior Manufacturing Bioprocess Associate-Drug Substance Process Operations

    1 week ago

    Dublin, Dublin City, Ireland PSC Biotech Full time

    Senior Manufacturing Bioprocess Associate - Drug Substance Process OperationsIndustry: Pharma/Biotech/Clinical ResearchWork Experience: 1-3 yearsCity: MeathState/Province: MeathCountry: IrelandJob DescriptionAbout PSC BiotechPSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with global operations in...