Job DescriptionOur client is a leading international Biotechnology company with a state of the art aseptic manufacturing facility in Dun Laoghaire, South Dublin.
The plant is one of the most dynamic in Ireland and is currently undergoing rapid expansion and capital investment.
This is an excellent opportunity to get experience on Ireland's leading aseptic manufacturing plant.This role will require the candidate to provide process development support to new product introductions (NPI) and lifecycle changes to site, provide subject matter expertise for unit operations and support ongoing production.
You will provide technical support to large molecule and small molecule drug product manufacturing as well as part of the global Process Development (PD) organization.
Client is currently operating with one RABS vial filling machine and one Syringe filling machine.
Two major projects are ongoing, one: to introduce an Isolator Vial Fill Line which is now in its qualification phase and two: the significant increase in output volume from the Syringe Fill Line.
Successful applicants will be directly involved in these projects.
The input provided will also include support of process performance and implementation of process improvement strategies and will include the following:Leads new product introductions and lifecycle changes into Vial filling and Syringe filling from a Process Development perspective and then serves as the Process Development SME for these products following completion of the transfer.Be a key contributor to regulatory filings as part of the NPI process throughout the authoring, editing and submission process but also be responsible for response to regulator questions as and when required.Acts as a drug product manufacturing technical expert to provide solutions when troubleshooting drug substance freezing/thawing, formulation, filling vials/syringes/devices, lyophilization, inspection, and transportation for parenteral products through the NPI or post-NPI phases.Provide process development expertise for commercial drug product processing in specific areas such as sterile processing, process characterization, tech transfer and validation.
Support commercial drug product manufacturing operations with technical evaluation of NC/CAPA and technology transfer.
Interfaces with manufacturing as well as all support functions to provide robust and coordinated support to manufacturing.Develops and characterizes drug product processes and transfers technology to commercial drug product sites.Identifies and implements operational opportunities for current and new sterile operations.Troubleshoots issues with drug product processing technologies and equipment.Leads and conducts risk assessment for drug product operations and propose / implement appropriate CAPA.Responsibilities may include leading cross-site teams to support the above activities, providing recommendations to management.Development and execution of validation plans, process performance qualifications (PPQs) for vial and syringe filling with a cross functional team.Ensuring all aspects of activity within any given process validation adheres to required policies and procedures, including safety and training.Ensure that the site meets the quality requirements of its customers and applicable regulations (FDA, EU & international standards).Assist in the development of any existing validation program to ensure continued compliance to the necessary regulations.Pre-approve and post-approve process validation protocols and assessments from a quality system documentation perspective.Contribute to product quality assessments and process flow documents.Liaise with Operations, Engineering and external vendors regarding new or amended equipment which would impact the validated product.Lead or assist in deviation and exception resolution and root cause analysis.Participate as required in project activities and be developing own project management techniques.RequirementsA third level Bachelor's degree in Science, Engineering or a relevant Quality discipline with 5 years' experience in a similar role OR Master's degree & 3 years of directly related experience OR Associate's degree & 10 years of directly related experienceKnowledge of cGMPs and other worldwide regulatory requirements.Problem solving ability and excellent oral and written communications skillsPreferred Qualifications:PhD or Masters in Science or Engineering5 + years of experience in support of Commercial Protein Drug Product (DP) processing in specific areas such as Sterile Processing, Process Characterization, Tech Transfer (to commercial DP sites) or Validation.Strong skills in applying fundamental engineering and scientific principles to the design, implementation and process validation of protein freeze-thawing, filtration, mixing, filling, and/or lyophilization processes.
Knowledge of protein biochemistry regarding chemical and physical stabilityProject management skills including the ability to manage multiple projects and evaluate project resource requirements.Strong knowledge of Quality systems, Drug Product Manufacturing and Validation.Demonstrated ability in providing leadership to cross-functional teams to advance complex projects to completion.
Excellent Communication skill is essential for this role.PackageCompetitive Hourly Rate of €40 - €47.50 per hourMinimum 12 month contract24/7 is not mandatory but may be required once or twice a year for one to two weeks at time 35% shift rate applies.Confirmed the shift patter: Its 2 days on 7am-7pm, 2 nights on 7pm-7am, 4 days off.
