Operations Lead

3 weeks ago


Dublin, Dublin City, Ireland Recruitment By Aphex Group Full time
Purpose 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.

Responsibilities Function as the site interface between the Product Delivery Teams (PDTs), 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 behaviors 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 SOPs, 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 and approve Bills of Materials Develop, review and update Product Quality Risk Assessments Qualifications Bachelors degree in a science discipline.

3+ 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 c GMP manufacturing and testing of pharmaceutical products.

Shift Patterns and On-call Cover: People required to go on a two-cycle shift pattern for the duration of each PPQ activities: 8 hour days operating over a 5 day week (Monday Friday) 2 week rota Week 1 Morning Shift: 07:00 15:00 (Mon Thurs) 07:00 14:00 (Fri) Week 2 Evening Shift: 14:30 22:30 (Mon Thurs) 13:30 20:30 (Fri) Alternating pattern, so if on morning shift week 1 then on evening shift week 2 and so on.

20% shift premium applied On-call cover for weekends from 07:00 Saturday 19:00 Sunday (excluding nights) Rostered on-call Must be able to attend site if required over both days Compensation is as per the on-call policy

  • Dublin, Dublin City, Ireland Lead Group Ireland Full time

    Lead Group Ireland are currently seeking a Lead Turnover Engineer for a contract position in South Dublin. This role is responsible for the handover of systems and documentation on a large pharmaceutical project. The ideal candidate will have a strong background in turnover management and pharmaceutical construction projects, with expertise in coordinating...


  • Dublin, Dublin City, Ireland Tether Operations Limited Full time

    Since its inception in 2014 by pioneering Bitcoin enthusiasts, Tether has not only launched the first 'stablecoin', USD₮, but also expanded its horizons into Tether Data, Tether Power, Tether Edu, and more. Our platforms and tokens lead in liquidity, stability, and innovation, setting the foundation for the future.Tether is committed to the extraordinary,...

  • Operations Lead

    20 hours ago


    Dublin, Dublin City, Ireland Lincoln Recruitment Specialists Full time

    Lincoln Recruitment Specialists is a leading business to business Insurance Intermediary, seeking an Operations Lead to oversee the operations of its business across Ireland and the UK.Job Summary:The Operations Lead will be responsible for managing the end-to-end insurance operations, including policy fulfillment, premium collection, claims administration,...


  • Dublin, Dublin City, Ireland Endo Operations Limited Full time

    Description The Senior Quality Specialist, Quality Operations leads an individual system and assists in managing the Quality System functions for cGxP manufacturing and distribution activities from local and Third Party manufacturing facilities. Provides quality guidance on product transfers and validations and will ensure that all activities related...

  • Operations Lead

    4 days ago


    Dublin, Dublin City, Ireland Orange Recruitment Full time

    Operations LeadThis is an exciting opportunity to join our team as Operations Lead, overseeing a key client account and driving business growth.Key Responsibilities:Develop and implement strategies to improve operational efficiency, reduce costs, and enhance service delivery.Lead a team of engineers and technicians, ensuring that all aspects of our clients'...

  • Operations Lead

    2 weeks ago


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

    Operations Lead (BBBH28229) Dublin, Republic of IrelandLSC have a great contract opportunity for an Operations Lead to join a South Dublin based Biopharmaceutical company that specializes in secondary manufacturing activities such as Formulation, Fill Finish and Packaging.ABOUT THE PROJECT – KEY RESPONSIBILITIES:Function as the site interface between the...

  • Operations Lead

    2 weeks ago


    Dublin, Dublin City, Ireland PE Global Full time

    Get AI-powered advice on this job and more exclusive features.Direct message the job poster from PE GlobalSenior Recruitment Consultant @ PE Global | Recruitment Consultant Science & EngineeringPE Global is currently recruiting for a Site Operations Lead for a leading multi-national client based in Dublin.This is a contract position.Role:In this role you...

  • Operations Lead

    3 weeks ago


    Dublin, Dublin City, Ireland PE Global Full time

    Get AI-powered advice on this job and more exclusive features.Direct message the job poster from PE GlobalSenior Recruitment Consultant @ PE Global | Recruitment Consultant Science & EngineeringPE Global is currently recruiting for a Site Operations Lead for a leading multi-national client based in Dublin.This is a contract position.Role:In this role you...

  • Operations Lead

    7 days ago


    Dublin, Dublin City, Ireland Team Horizon Full time

    Operations LeadTeam Horizon is seeking a Operations Lead for a pharmaceutical client in Dublin. The Operations Lead will serve as primary production process owner responsible for New Production Introduction, lice cycle management projects and or CAPEX projects and established process improvements projects.This role requires in depth technical and operational...

  • Operations Lead

    2 weeks ago


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

    LSC have a great contract opportunity for an Operations Lead to join a South Dublin based Biopharmaceutical company that specializes in secondary manufacturing activities such as Formulation, Fill Finish and Packaging. ABOUT THE PROJECT - KEY RESPONSIBILITIES: Function as the site interface between the Product Delivery Teams (PDT's), and Manufacturing...

  • Operations Lead

    3 weeks ago


    Dublin, Dublin City, Ireland Life Science Consultants Full time

    LSC have a great contract opportunity for an Operations Lead to join a South Dublin based Biopharmaceutical company that specializes in secondary manufacturing activities such as Formulation, Fill Finish and Packaging.ABOUT THE PROJECT - KEY RESPONSIBILITIES: Function as the site interface between the Product Delivery Teams (PDT's), and Manufacturing...

  • Operations Lead

    2 days ago


    Dublin, Dublin City, Ireland Synergy Recruitment Partners Full time

    About the RoleThe Operations Lead will be responsible for overseeing the day-to-day operations of the project, ensuring that it runs smoothly and efficiently. This includes managing the team, coordinating tasks, and identifying areas for improvement.A key aspect of this role is building relationships with stakeholders, including customers, suppliers, and...


  • Dublin, Dublin City, Ireland Vhi Full time

    Job Summary:We are seeking an exceptional leader to join our Central Operational Support Unit as Head of Central Operations Health and Wellbeing. This is a critical role that requires a highly motivated and experienced individual who can drive operational excellence and lead cross-functional teams.About the Role:Consolidate and develop the Central...


  • Dublin, Dublin City, Ireland EA First Compass House Full time

    We are excited to partner with a leading global organization in Dublin, Ireland, that is seeking a highly skilled Technical Operations Lead - Europe. This forward-thinking company plays a vital role in reducing the carbon impact of packaging worldwide.With operations spanning multiple continents, this successful client has recently completed a significant...

  • Operations Lead

    20 hours ago


    Dublin, Dublin City, Ireland Mad Egg Full time

    Operations Lead @ Mad Egg Dublin / Nationwide Why work with Mad Egg?Does this appeal to you?Grow and develop an innovative and people centric restaurant management team Support our mission to deliver remarkable experiences to our people and our customers    Join a fast growing company on the path to become the #1 chicken joint in Ireland Launch and...

  • Operations Lead

    5 days ago


    Dublin, Dublin City, Ireland Team Horizon Full time

    Team Horizon is seeking an Operations Lead for a pharmaceutical client in Dublin. The Operations Lead will serve as the primary production process owner responsible for New Production Introduction, lifecycle management projects, and CAPEX projects, as well as established process improvement projects.This role requires in-depth technical and operational...

  • Operations Lead

    20 hours ago


    Dublin, Dublin City, Ireland Team Horizon Full time

    Team Horizon is seeking an Operations Lead on behalf of a biopharmaceutical manufacturer in Dublin.In this role you serve as primary production process owner responsible for New Product Introduction, Life Cycle Management Projects and/or CAPEX projects and established process improvements projects Why you should apply: This is an excellent opportunity to...

  • IT Operations Lead

    2 days ago


    Dublin, Dublin City, Ireland TieTalent Full time

    TieTalent is seeking an experienced IT professional to lead and oversee our organization's information technology operations. As Chief Information Officer, you will be responsible for managing the IT team, ensuring the optimal performance of IT systems, infrastructure, and technology solutions.Job Requirements:Technical Expertise: Extensive technical...


  • Dublin, Dublin City, Ireland Lincoln Recruitment Specialists Full time

    Engineering Operations LeadOur client, a leading civil and engineering company, is seeking an experienced Engineering Operations Lead to oversee their infrastructure projects.About the RoleThe successful candidate will lead a team of engineers and coordinate with stakeholders to deliver projects on time and within budget.Lead project planning, execution, and...

  • Operations Lead

    3 weeks ago


    Dublin, Dublin City, Ireland Team Horizon Full time

    Team Horizon is seeking an Operations Lead for a pharmaceutical client in Dublin. The Operations Lead will serve as the primary production process owner responsible for New Production Introduction, lifecycle management projects, and CAPEX projects, as well as established process improvement projects.This role requires in-depth technical and operational...