Exec. Dir., Operations

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