Job Description We are currently seeking an experienced Senior Specialist, Safety & Environment to join the Environmental Health & Safety (EHS) team at our Biotech site. You will join a dedicated team and will play an integral role in developing, maintaining, and continually improving the EHS systems at our world-class biologics facility in Dublin. Job Description We are currently seeking an experienced Senior Specialist, Safety & Environment to join the Environmental Health & Safety (EHS) team at our Biotech site. You will join a dedicated team and will play an integral role in developing, maintaining, and continually improving the EHS systems at our world-class biologics facility in Dublin. You will provide technical guidance to the organisation to ensure compliance with legal requirements related to EHS as well as the company’s corporate standards, policies, procedures, and guidelines related to EHS and industry best practices. You will also ensure in conjunction with the EHS team that all health and safety regulatory requirements on the site are upheld to the highest standard while playing a key role in the future development and maintenance of all EHS functions at our Dublin facility. What You Will Do Bring energy, knowledge, innovation and leadership to carry out the following: Develop, implement and maintain the following technical EHS programmes to ensure compliance with local legislation, company standards, and industry best practices. Process Safety, Machine & Equipment Safety, High Risk Work (Electrical Safety, Hazardous Energy Control, Line Breaking), Contractor Management, Management of Change, EHS Risk Assessment, Fire Safety, and Loss Prevention. Evaluate EHS systems, programs and procedures for compliance and improvement by reviewing, auditing and carrying out inspections. Manage day to day EHS queries, technical support, and machine / plant/ process or equipment safety issues if present. Assist operational departments in achieving and establishing compliance. Demonstrate leadership and a strong desire to protect employees, our community, and the environment in this world-class facility – leading with a ’safety first’ mindset. Prepare relevant reports to site, divisional and/or corporate management and regulatory agencies. Maintain a high standard of documentation in relation to all activities. Provide leadership, support and guidance to other members of the EHS Team and the site, as appropriate. Evaluate all EHS applicable requirements for any new projects and processes (along with other site departments where necessary) as well as changes in the existing processes and installation. Other duties as assigned. What Skills You Will Need In order to excel in this role, you will need: Bachelor’s degree in environmental, Safety, Engineering, or Science. 7+ years EHS experience in a manufacturing facility - Pharmaceutical, or other highly regulated industry. Process Safety, Equipment Safety, and High-Risk Work experience. Proven record of success in the EHS sector. Experience on supporting multiple activities/projects. Experience in managing and implementing change. Strong ability to influence others across departments and at all levels of the organization. Technically strong; with understanding of a variety of EHS topics. Innovative & compliance-minded, with the drive to go seek out necessary information. ‘Safety First’ mind-set. Desire to protect employees and environment. Collaborator capable of working within a multi-functionary team environment. Ability to lead teams, complex projects and initiatives. Enthusiastic with a strong drive for results. Self-directed, capable of using own initiative to make EHS improvements. Dedicated to maintaining high standards, with the courage and candour to ensure things are done properly onsite – ‘right first time.’ We are proud to be a company that embraces the value of bringing talented and committed people together. The fastest way to breakthrough innovation is when varied ideas come together in an inclusive environment. Required Skills Accountability, Accountability, Adaptability, Biopharmaceuticals, Biopharmaceutics, Biosafety, Contractor Management, Corporate Management, EHS Auditing, EHS Compliance, EHS Program Management, Electrical Safety, Environmental Regulatory Compliance, Fire Safety, Health and Safety Legislation, Housekeeping, Incident Investigations, Industrial Hygiene, Interpersonal Relationships, Leadership, Legal Compliance, Lockout Tagout, Machinery Safety, Occupational Safety and Health Programs, Process Safety Management {+ 4 more} Preferred Skills Current Employees apply HERE Current Contingent Workers apply HERE Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status Regular Relocation: VISA Sponsorship Travel Requirements: Flexible Work Arrangements Not Applicable Shift Valid Driving License: Hazardous Material(s) Job Posting End Date: 03/24/2026 A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID: R388188 #J-18808-Ljbffr
A leading biopharmaceutical company in Dunboyne is seeking an Operations Executive Director for its Biologics clinical and commercial manufacturing. The role involves overseeing all manufacturing operations, ensuring compliance with regulatory standards, and driving operational excellence. The successful candidate will have over 15 years of experience in a cross-functional manufacturing role and a technical degree. This position offers leadership opportunities across multiple facilities with a focus on cultivating a high-performance culture. #J-18808-Ljbffr
Job Description A fantastic and hugely exciting opportunity has arisen for an Operations Executive Director for Biologics clinical and commercial manufacturing at our single-use, multi-product commercialization facility in Dunboyne. Reporting to the Site Lead, this position will drive transformational change for capacity realization and operational excellence to deliver all components of stable manufacturing teams and processes for a diverse and complex Biologics pipeline. This is a new position to establish single accountability across all manufacturing Operations at the site and to drive standardization and simplified ways of workings for optimal utilization and resource agility. This position will provide leadership and operations support on Biologics drug substance (DS) and cell banking manufacturing and release in addition to technology transfer, PPQ, inspection readiness and approval of new products. This position will include leadership across five facilities and 300 personnel within the organization, including days and shift teams. Bring Energy, Knowledge, Innovation To Carry Out The Following Responsible for all Manufacturing Operations within four state of the art multi-product facilities used for clinical and commercial manufacture of Biologics Drug Substance, a Cell Banking facility and associated Weigh/Dispense and Solution Prep activities. Plans and directs all aspects of production activities associated with manufacturing or technology transfer and ensures that all projects, initiatives and processes are in conformance with established policies, standards and objectives. Serves on the Site Leadership Team for Operations to develop and deliver toward site and organizational priorities and strategy. Ensure right-first-time and stable start-up, including through technology transfer leadership, execution of clinical, PPQ and commercial batches, change management and implementation of process improvements. Drive a strong compliance mindset within the organisation, including proactive safety and quality culture, and adherence to all regulatory expectations. Ownership for ensuring permanent inspection readiness is in place. Ensure production and project milestones are achieved through planning and execution of integrated overall program schedule. Establish and deliver on KPI’s in a timely manner, including schedule adherence, training, hiring, uptime, change controls, investigations, CAPAs, capital/expense targets, sustainability targets, yield/volume/cadence/operational availability, Right First Time, and timely documentation closure. Drive standardization, execution and operational excellence by applying Lean principles to foster continuous improvement mindset to deliver a productive and cost-efficient operating model. Manage and develop operations team personnel toward strong, empowered leaders. Build, inspire, reward and develop diverse talent with the capabilities necessary to succeed in manufacture. Develop facility and resource capacity model across all Operations on site. Resolve resource and prioritisation constraints and support resource needs and changes. Drive a strong technical and digital mindset within the department, staying up to date with emerging technologies that will benefit the organization and manufacturing processes. Resolve issues and identify risks in a timely fashion to the relevant on-site and above-site stakeholders. Responsible for prioritisation of proposed risk mitigation plans and/or acceptance of Quality Risks identified as part of the Quality Risk Management Process. Provide clear direction and definition of any new project scope, goals and deliverables, to the site and cross-functional sub-teams on an on-going basis. Resolve issues and identify risks in a timely fashion to the relevant on-site and above-site Stakeholders. Manage financial forecasts and workload to achieve departmental headcount and cost improvements. General Competencies Strong leadership and interpersonal skills, including leading and coaching direct team to drive a high performance organizational culture that accommodates rapid growth & highly dynamic operating execution. Inspirational leader that leverages data to set the vision and drive outcomes. The desire to continuously learn, improve and grow, and cultivate continued development within the team Innovative thinker, with excellent decision-making and problem-solving skills. Ability to participate in and lead highly effective cross functional teams, build diverse talent, with a passion to build the future of the Dunboyne facility. Ability to influence across organizational layers, as well as outside the site and externally with partners and based on industry benchmarking. Ability to rapidly understand complex business & technical issues including multi-option scenarios to mitigate risk and ensure continuity of supply as well as strategic initiatives. A great communicator, decisive decision maker with a proven ability to deliver excellence. Technical Competencies Proven capabilities in site manufacturing and technical operations, experience of Operational Excellence, Six Sigma and Lean Methodologies and a proven track‑record in project management. Proven capabilities and knowledge of Biologics Drug Substance manufacturing, particularly in downstream processes. Set clear performance standards; overcome obstacles; hold ourselves and others accountable for achieving results. Knowledge of global and company health authority regulations and applicable systems & GMP requirements. Experience engaging with regulatory agencies including in on‑site inspections. Sound judgment and comfortable operating in a challenging, fast‑paced and sometimes ambiguous environment. Minimum Education/Experience Degree qualification or equivalent (Science, Engineering, Technical or other relevant studies). Demonstrated leadership with at least 15 years leading in a cross‑functional manufacturing environment, including indirect or direct people management experience. Demonstrated Biologics manufacturing and technology transfer experience. Required Skills Accountability, Accountability, Change Agility, Consulting, Cross‑Cultural Awareness, Data-Driven Decision Making, Decision Making, Driving Continuous Improvement, Equipment Set Up, Fabrication Processes, GMP Compliance, Leadership, Lean Design, Lean Management, Management Process, Manufacturing Processes, Manufacturing Quality Control, Operational Excellence, Organizational Culture, People Leadership, Production Scheduling, Project Management, Raw Material Specifications, Regulatory Compliance, Science {+ 5 more} Preferred Skills Current Employees apply HERE Current Contingent Workers apply HERE Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status Regular Relocation VISA Sponsorship Travel Requirements Flexible Work Arrangements Not Applicable Shift Valid Driving License Hazardous Material(s) Job Posting End Date 04/3/2026 A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID: R390933 #J-18808-Ljbffr
Job Description A fantastic opportunity is available for an Executive Director of MS&T to serve as the senior technical leader for our Biologics, single-use, multi-product clinical and commercial manufacturing campus in Dunboyne . This role is central to shaping the future technical capability of the site and delivering sustained excellence across a complex and growing biologics portfolio. Reporting to the Head of Biologics DS Technical Operations , the Executive Director will define and execute the technical vision for the site , driving end-to-end technical excellence across Technical Operations, Process Sciences laboratories, and technology transfer. The role is accountable for accelerating the successful commercialization of a diverse and complex biologics pipeline while ensuring robust, compliant, and reliable manufacturing of commercial products. This newly created position establishes single-point accountability for end-to-end technical performance , integrating upstream and downstream technical operations, process sciences, and other technical functions into a cohesive technical operating model. The Executive Director will provide transformative, hands‑on leadership across biologics drug substance manufacturing at the site where the technical operations team will be involved in model development, process characterization and scaleup within Process Sciences laboratories. The team will also directly support PPQ execution, filing and inspection readiness. Core Responsibilities Technical Ownership & Process Stewardship Serve as the technical owner for site New Product Introduction and Technology Transfer, ensuring a deep, end-to-end understanding of the technical interdependencies between process science and manufacturing execution to enable on-time, right-first-time site and process introduction. Act as the senior onsite technical authority and escalation point during PPQ, early commercial manufacture, and transfers to new nodes, ensuring rapid, decisive resolution of complex technical issues. Hold full accountability for the creation, approval, and lifecycle management of critical site documentation required to support production readiness, including batch records, recipes, and sampling strategies. Provide technical leadership in response to regulatory questions impacting site operations, partnering closely with site CMC to support submissions, commitments, and post-approval changes. Partner with Quality and Operations leadership to support Regulatory information requests, including risk management, deviations, audits, and inspection readiness. Represent site and operational considerations within commercialization and development forums, ensuring manufacturability and scalability are embedded early in development. Lead product lifecycle management activities, implementing process improvements that enhance long-term robustness, compliance, and productivity through disciplined application of MPS. Champion and support execution of the site digital and data strategy to strengthen technical insight and operational performance. Investigations, Root Cause Analysis & Complex Problem Solving Lead high impact, complex investigations (including deviations, OOS/OOT, and contamination or impurity events), setting the standard for rigorous, data-driven root cause analysis and sustainable corrective and preventive actions. Establish and leverage site-level laboratory and scale-down capabilities that serve as the authoritative standard for complex drug substance manufacturing support and advanced analytical investigations, driving continuous improvement through targeted experimentation. Create a strong feedback loop between manufacturing and development organizations, ensuring learnings from commercial supply directly inform process development and networkwide operations. Risk Management, Monitoring & Preventive Action Establish and lead Proactive Process Monitoring strategies from pre-PPQ through the full product lifecycle, including cross-site performance monitoring. Own technical performance stewardship for commercial drug substance processes, proactively identifying and addressing risks to supply, quality, and compliance. Lead cross-site and cross-program technical risk reviews, translating trend data into timely, effective mitigation strategies. Own stewardship of product, process, and unit operation knowledge management to ensure organizational learning and continuity. Change Control, Validation, QMS & Inspection Readiness Own and execute the technical change control strategy, including multisite change assessments and regulatory impact evaluations. Demonstrate deep expertise in the company QMS, providing rapid, authoritative technical responses and defensible evidence packages for regulatory inspections and internal audits, with unwavering focus on data integrity and traceability. Provide leadership across core QMS processes, including APR/CPV, validation, deviations, inspections, and regulatory submissions. Technical Excellence & Innovation (Leadership Accountability) Build and sustain best-in‑class technical capability at the site, ensuring critical competencies and succession plans are in place and aligned across the network. Lead and enable continuous improvement by shaping how work is performed, identifying opportunities to simplify, standardize, and streamline while maintaining full compliance. Drive external collaboration with academic and research institutes to strengthen the technical talent pipeline and advance innovation in areas of strategic importance. Who You Are Advanced degree (B.S., M.S., or Ph.D.) in Engineering or a relevant scientific discipline. Minimum of 15 years’ experience in biopharmaceutical manufacturing and/or development, with a strong foundation in technical and scientific leadership roles. Deep expertise in biologics molecules, drug substance manufacturing, and commercialization. Proven experience leading technical operations at a manufacturing site, including new product introduction and technology transfer. Demonstrated success in regulatory interactions, investigations, and CAPA management. A recognized leader with the ability to influence and align stakeholders at all levels of the organization. Strong talent building capability, combining strategic thinking with operational discipline. Solid business and financial acumen, with the ability to manage multiple, complex programs concurrently. A leadership style characterized by urgency, accountability, change agility, and the ability to inspire high performance. Required Skills Accountability, Availability Management, Business Development, Change Controls, Incident Management, Leadership, Management System Development, Problem Management, Quality Assurance (QA), Service Delivery, SLA Management, Software Configurations, Software Development Life Cycle (SDLC), Testing Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status Regular Relocation VISA Sponsorship Travel Requirements Flexible Work Arrangements Shift Not Applicable Valid Driving License Hazardous Material(s) Job Posting End Date 04/3/2026 Requisition ID R390867 #J-18808-Ljbffr
