MSD Operations Director Upstream 

Ireland 

269763775

Bring energy, knowledge, innovation to carry out the following:

Responsible for Upstream Operations within a state of the art multi-product facility used for clinical and commercial manufacture of Biologics Drug Substance.

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 Our Company established policies, standards and objectives.

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,availability, Right First Time, and timely documentation closure.

Drive execution and operational excellence by applying Lean principles to foster continuous improvement mindset to deliver a productive and cost-efficient operating model.

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.

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.

Innovative thinker, with excellent decision-making and problem-solving skills.

Ability to influence across organizational layers, as well as outside the site and externally with partners.

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 upstream 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.

Degree qualification or equivalent (Science, Engineering, Technical or other relevant studies).

Demonstrated leadership with at least 5 years leading in a cross-functional environment, including indirect or direct people management experience.

manufacturing site, project or other relevant experience.