LSC have a great contract opportunity for a NPI QA Specialist to join a biopharmaceutical company in Dublin focused on serving patients with severe and ultra-rare disorders through the innovation, development and commercialization of life-transforming therapeutic products. If you have 5 years of experience working in the pharmaceutical or biotechnology industry and are ready for your next challenge, this could be the perfect opportunity for you! ABOUT THE PROJECT - KEY RESPONSIBILITIES: Quality Oversight on new product introduction in Bulk Drug Substance facility . Site QA responsibility to provide technical expertise for all QA and compliance topics Review and Approve project documents involving cross-functional, multi-departmental teams including: Operations, Process Engineering, Quality Control, Quality Assurance, Facilities, and Packaging Quality oversight on operations and technical services to review and approve Process descriptions , sampling plans, operational procedures, process validation and cleaning validation documents . Review and Approve TRA's, MSRs, SAP requests related to new products . ABOUT YOU - ARE YOUR SKILLS A MATCH? Third level qualification e.g. B.Sc. in science/pharmacy with a minimum of 5 years' experience in cGMP Quality environment; or equivalent combination of education and experience. Experience of sterility assurance for drug products and in manufacturing processes for pharmaceutical products and processes strongly desirable. Direct experience of GMP management within a pharma/biopharma company is essential, and will include exposure to FDA, HPRA/EMA or other authorities of similar standing. Note: Are you currently eligible to work in Ireland? As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply! Apply via this advert or contact Kathy Gillen at LSC on if you have any more questions about this role! TPBN1_IJ
LSC have a great contract opportunity for a QC Analyst to join a biopharmaceutical company in Athlone focused on serving patients with severe and ultra-rare disorders through the innovation, development and commercialization of life-transforming therapeutic products. If you have 3+ years of experience working in the biochemistry, pharmaceutical or biotechnology industry and are ready for your next challenge, this could be the perfect opportunity for you! ABOUT THE PROJECT - KEY RESPONSIBILITIES: The QC Analyst will support Chemistry and Microbiological product testing and environmental monitoring for Drug Product and Drug Substance manufacture. The QC analyst will also provide technical support with regard to facility testing oversight, test method validation and introduction of new technology to the laboratory. The QC analyst will be an SME on product testing and environmental monitoring with responsibility for investigation and report writing. ABOUT YOU - ARE YOUR SKILLS A MATCH? Perform analytical testing and environmental monitoring sampling and testing for all cleanroom facilities Ensuring high cGMP and GLP standards are maintained while testing by adapting a right first time approach Ensure all safety requirements within the lab are adhered to at all times and identify and escalate any safety concerns appropriately. Adherence to schedules and targets to meet regulatory and business requirements. Validation/Qualification of Microbiology and Chemistry analytical test methods and testing systems including the generation of associated reports. Represent QC department in internal and external audits where appropriate and close out of actions/ recommendations identified from both internal and external audits. Perform technical review of data generated in laboratory, validation protocols and reports and provide technical support to Manufacturing and Projects Actively identify and implement continuous improvement initiatives with the QC lab Investigate out of specification/limit results utilizing Structured Problem Solving, Root Cause Analysis tools in conjunction with the Laboratory Supervisor, QA and other relevant departments and to implement effective corrective and preventative actions while ensuring all investigations are closed with the specified lead-time. ABOUT YOU - ARE YOUR SKILLS A MATCH? BSc (Hons) in biosciences (e.g. Microbiology/Chemistry etc.) and 3 years' experience in a cGMP in a QC laboratory environment and laboratory equipment associated with biopharmaceutical analysis. The position requires the ability to understand and follow written SOPs, to accurately and legibly record work in real time, and pay close attention to detail. The individual must be able to perform routine tasks with a minimum of supervision. The individual should have a strong understanding of lab safety and demonstrated ability to recognize and mitigate safety risks. Strong technical writing and report writing skills Experienced in the use of gLIMs Experience in both Chemistry (HPLC, UV) and microbiological technique Note: Are you currently eligible to work in Ireland? As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply! Apply via this advert or contact Jenny Murphy at LSC on if you have any more questions about this role! TPBN1_IJ
LSC have a great contract opportunity for a Sr QC Equipment Support Analyst to join a South Dublin based Biopharmaceutical company that specializes in secondary manufacturing activities such as Formulation, Fill Finish and Packaging. If you have 5+ years of experience working in the pharmaceutical or biotechnology industry and are ready for your next challenge, this could be the perfect opportunity for you! ABOUT THE PROJECT - KEY RESPONSIBILITIES: Planning and conducting routine calibration, requalification and maintenance of laboratory equipment ensuring calibration and maintenance schedules are adhered to as per CMMS Maximo. Reviewing & filing of QC calibration & maintenance documentation. Planning, executing and documenting the qualification of new laboratory equipment in a cGMP regulated environment, including the writing of equipment validation protocols and associated summary reports. Conduct periodic reviews of instrument validation as part of validation life cycle. Alerting Quality Control Management in the event of equipment failing to meet calibration or qualification requirements and conducting impact assessments/investigations as required. Scheduling and coordination of equipment repairs and maintenance with vendors/contractors, while minimizing level of down-time for lab equipment, and disruption to laboratory activities. ABOUT YOU - ARE YOUR SKILLS A MATCH? Bachelor's degree in a Science related field is required. Minimum of 5 years of laboratory experience in a cGMP laboratory environment including exposure to analytical instrument validation and data integrity assessments. Detailed knowledge of the methodology, and instrumentation and analytical techniques used for biopharmaceutical testing. Note: Are you currently eligible to work in Ireland? As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply! Apply via this advert or contact Kathy Gillen on if you have anymore questions about this role! TPBN1_IJ
LSC has an exciting opportunity for a Quality Assurance External Manufacturing representative to join a leading pharmaceutical company in Cork. This is is a chance for you to work with a global company that strives for excellence in every aspect of its operation and has a huge reputation for its diverse working culture. If you have a minimum of 3 years of experience working in the pharmaceutical or biotechnology industry and are ready for your next challenge, this could be the perfect opportunity for you! ABOUT THE PROJECT - KEY RESPONSIBILITIES: Description: The DRY External Manufacturing Quality Assurance Contractor provides support to all quality activities at Contract Manufacturing organizations (CMs). The QA Contractor's position is essential for ensuring that all batches meet specifications, are manufactured in accordance with the validated process and are compliant to cGMPs and regulatory commitments. Key Objectives/Deliverables: * Escalate quality issues at CMs to QA management. * Assist in the establishment and revisions of Quality Agreements with affiliates and customers. * Ensure compliance to Quality Agreements and Manufacturing Responsibilities Documents (MRDs). * Coordinate and perform QA responsibilities of API shipments. * Participate in regulatory inspection preparations with CMs. Provide on-site support during inspections. * Participate on the Technical Review Board * Evaluate and disposition API batches, if required. * Ensure that documented checks have been completed for the Certificates of Testing and Certificates of Environmental Monitoring (where applicable), and deviations, changes and batch documentation that demonstrates requirements have been met prior to batch release. * Provide quality support of API manufacturing with the focus on holistic review of key activities associated with or impacting the manufacturing processes including deviations, change controls and countermeasures. * Ensure all processes are in an appropriate state of control. * Participate in APR activities. * Participate in Joint Process (JPT) and Post Launch Optimization (PLOT) Teams. Basic Requirements: * BS in a science-related field such as Pharmacy, Chemistry, Biological Sciences or related Life Sciences. * Previous GMP manufacturing knowledge and/or experience in API or finished product manufacturing, QC, QA or Engineering Additional Preferences: * Experience in quality support for Quality Control activities * Knowledge of pharmaceutical manufacturing operations. * Demonstrated coaching and mentoring skills. * Experience in root cause analysis. * Demonstrated application of statistical skills. * Demonstrated strong written and verbal communications skills. * Strong attention to detail. * Proficiency with computer system applications. * Excellent interpersonal skills and networking skills. Education Requirements: * BS in a science-related field such as Pharmacy, Chemistry, Biological Sciences or related Life Sciences. Note: Are you currently eligible to work in Ireland? As this is a contract opportunity you will need to hold a valid Stamp 1G/Stamp 4 visa to apply! Apply via this advert or contact Siobhan Cummins at LSC on if you have any more questions about this role! TPBN1_IJ
LSC have a great contract opportunity for a NPI Senior Analyst to join a biopharmaceutical company in Dublin focused on serving patients with severe and ultra-rare disorders through the innovation, development and commercialization of life-transforming therapeutic products. If you have 4 years of experience working in the pharmaceutical or biotechnology industry and are ready for your next challenge, this could be the perfect opportunity for you! ABOUT THE PROJECT - KEY RESPONSIBILITIES: Perform all lab functions in compliance with cGMP Follow written protocols for Transfer and Validation activities Troubleshoot new methods as required Ensure training is current for all job functions performed Provide QC SME and day to day technical guidance for NPI activities Support the NPI management team as required ABOUT YOU - ARE YOUR SKILLS A MATCH? In depth knowledge of current regulatory requirements for Chemistry or Biochemistry methods in support of cGMP operations supporting clinical and commercial manufacturing Good technical knowledge in the area of Biochemistry or Chemistry. BSc in Chemistry or a biological science, 4-7 years' experience, or equivalent combination of education and experience.= Note: Are you currently eligible to work in Ireland? As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply! Apply via this advert or contact Kathy Gillen at LSC on if you have any more questions about this role! Skills: NPI Quality Control Biochemistry TPBN1_IJ
LSC have a great contract opportunity for a QC Biochemistry Reviewer to join a biopharmaceutical company in Dublin focused on serving patients with severe and ultra-rare disorders through the innovation, development and commercialization of life-transforming therapeutic products. If you have 5 years of experience working in the pharmaceutical or biotechnology industry and are ready for your next challenge, this could be the perfect opportunity for you! ABOUT THE PROJECT - KEY RESPONSIBILITIES: The QC Biochemistry Reviewer (Senior Analyst) is responsible for providing technical and laboratory support to the QC analysts Follow written procedures for review of the following tests, as trained and qualified: Gel electrophoresis (SDS-PAGE, IEF), ELISA and plate based assays (potency and residual assays such as HCP and ProA), Protein concentration Release, stability and in-process review scheduling and testing. Recognize and report aberrant test results and sample conditions. Provide QC SME and day to day technical guidance to QC biochemistry analysts ABOUT YOU - ARE YOUR SKILLS A MATCH? BSc in Biochemistry or a biological/chemistry science, with 4-7 years' experience, or equivalent combination of education and experience. A working knowledge of the cGMP QC laboratory environment, and equipment associated with testing of biopharmaceutical products A working knowledge of gel electrophoresis and ELISA assays (Softmax software) Note: Are you currently eligible to work in Ireland? As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply! Apply via this advert or contact Jenny Murphy at LSC on if you have any more questions about this role! Skills: Gel electrophoresis ELISA and plate based assays Protein concentration TPBN1_IJ
LSC have a great contract opportunity for a QC Chemistry Senior Analyst to join a biopharmaceutical company in Dublin focused on serving patients with severe and ultra-rare disorders through the innovation, development and commercialization of life-transforming therapeutic products. If you have 3 + years of experience working in the pharmaceutical or biotechnology industry and are ready for your next challenge, this could be the perfect opportunity for you! ABOUT THE PROJECT - KEY RESPONSIBILITIES: Perform all lab functions in compliance with cGMP. Follow written procedures for the following tests, as trained and qualified. Stability scheduling and testing. Recognize and report aberrant test results and sample conditions. Provide QC SME and day to day technical guidance to QC Chemistry analysts. Training of new analysts in specific assays. Drive continuous improvement initiatives within the QC department. Lead and complete execution of investigations/CAPAs in a timely manner. Provide lab support including reagent preparation, cleaning, and routine equipment maintenance. ABOUT YOU - ARE YOUR SKILLS A MATCH? BSc in Chemistry or a biological science, 3 + years' experience with HPLC analysis in a GLP laboratory setting. Note: Are you currently eligible to work in Ireland? As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply! Apply via this advert or contact Jenny Murphy at LSC on if you have any more questions about this role! Skills: Quality Analyst Quality Control Senior Chemistry Pharmaceuticals Life Science TPBN1_IJ
LSC have a great contract opportunity for an Engineering Administrator with a large pharmaceutical company based in Cork. If you have 3+ years relevant experience in a GMP environment related field and ready for your next challenge, this could be the perfect project for you! ABOUT THE PROJECT - KEY RESPONSIBILITIES: Deliver engineering excellence in the fundamentals to optimise asset availability and capital project execution, so that the business achieves its targets. Equipment availability and reliability (supply): Support the repair and maintenance program on site to ensure equipment reliability and availability while meeting compliance requirements. Provide Work Order Management support and reports to Area Teams Review and file PM / CAL work orders Maintain CMMS database e.g. CMMS Change Control, Out of Compliance, Out of calibration, asset addition / updates Provide support to all users of the site CMMS and train new users Purchase Requisition support for area teams Carry out compliance audits for IFM soft services work management program Maintain Maintenance Library Support Travel and Hospitality requirement for the department Shutdowns: Support for the safe completion of the maintenance programme of work during the annual shutdown and start-up Ensure adequate admin support in preparation of shutdown plans Provide work management reports as required Capital projects: Support the annual capital plan and delivery of all capital projects within Engineering Area Engage with capital projects from the start of the project lifecycle to ensure that equipment purchased is inputted onto the CMMS Provide back up for requisitioning for capital projects. Cost: Deliver all activities in Engineering area within budget and with target headcount; Attend site requisitioners meeting to track spend by area Actively manage Invoice holds / PO reconciliation Place Stationary orders for the department Quality: Support adherence to all quality standards in Engineering area Support compliance on Quality PM's and calibrations, weekly / monthly work order compliance reports Implementing SQE standards/initiatives as required / actioned Up to date procedures / followed always - Review procedures / guidelines to ensure that they reflect current practice. Provide Audit support internal / external Compliance on Individual JFC training Safety: Support adherence to all safety standards in Engineering Support compliance on EHS PM's and calibrations and statutory regulations, weekly / monthly work order compliance reports Provide Audit support internal / external Order PPE for the department Partake in SQE standards/initiatives as required / actioned Proactive approach re SIMS reporting Maintain zero overdue Safety Actions throughout the year Actively partake in Department Safety meetings Compliance on Individual JFC training People: Engage and enhance individual and team performance Proactive approach to individual and team objectives Manage department TMS. ABOUT YOU - ARE YOUR SKILLS A MATCH? Minimum requirement of 3rd level qualification in a relevant discipline and will have experience working in relevant industry. Requirement to have strong skill set in Documentation Control and a proficiency in IT applications To be highly motivated and be able to demonstrate strong interpersonal and communication skills, as well as possessing problem solving and decision making abilities Experience of working in a Pharmaceutical / Audit ready environment and knowledge of an engineering environment would be an advantage Complete Engineering Administration JFC Program Note: Are you currently eligible to work in Ireland? As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply! Apply via this advert or contact Siobhan Cummins at if you have any more questions about this opportunity! TPBN1_IJ
LSC have a great contract opportunity for a QC Senior Analyst to join a biopharmaceutical company in Dublin focused on serving patients with severe and ultra-rare disorders through the innovation, development and commercialization of life-transforming therapeutic products. If you have 4 years of experience working in the biochemistry, pharmaceutical or biotechnology industry and are ready for your next challenge, this could be the perfect opportunity for you! ABOUT THE PROJECT - KEY RESPONSIBILITIES: Perform all lab functions in compliance with cGMP. Follow written procedures for the following tests, as trained and qualified: Gel electrophoresis (SDS-PAGE, IEF). ELISA and plate-based assays (potency and residual assays such as HCP and ProA). Stability scheduling and testing. Recognize and report aberrant test results and sample conditions. Provide QC SME and day to day technical guidance to QC biochemistry analysts. Lead and complete execution of investigations/CAPAs in a timely manner. Provide lab support including reagent preparation, cleaning, and routine equipment maintenance. ABOUT YOU - ARE YOUR SKILLS A MATCH? BSc in Chemistry or a biological science 4-7 years' experience with experience in gel electrophoresis (SDS-PAGE, IEF), ELISA and plate-based assays A working knowledge of the cGMP QC laboratory environment, and equipment associated with testing of biopharmaceutical products. Note: Are you currently eligible to work in Ireland? As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply! Apply via this advert or contact Kathy Gillen at LSC on if you have any more questions about this role! Skills: QC Senior TPBN1_IJ
LSC has an exciting opportunity for a Supply Chain Associate - Customer Service to join a pharmaceutical company in Cork. Overview: The role is a hybrid of supply chain and project management, focusing on managing relationships with contract manufacturers (CMOs) Key responsibilities: Setting up supply chain processes between new suppliers and the client Master data management using various tools including SAP Reconciling inventory Organizing shipments Processing POs on SAP - Experience with SAP and strong attention to detail are essential Education & Requirements: Level 8 degree Additional qualifications in Procurement, Supply Chain, or Logistics and shipping (IIPMM, IPICS, APICS) are advantageous. Minimum of 3 years' experience in Supply Chain, Customer Service, Logistics, Compliance, or Operations. Strong computer skills, particularly SAP or similar systems, and MS Office (especially Excel). Preferred Experience in pharma contract or toll manufacturing. Experience in multinational organizations. Note: Are you currently eligible to work in Ireland? As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply! Call Siobhan Cummins LSC on to discuss in detail or apply directly via this advert. TPBN1_IJ
