Launch Excellence Leader (Assoc. Dir.)

Job Description

A fantastic opportunity has arisen for a Launch Excellence Leader (AD Project Mgmt.) at our site in Dunboyne, Co. Meath.

The Launch Excellence Leader is a cross-site, cross-functional transformation role within the GBO Network Launch Readiness organization, focused on improving key business processes that enable effective New Product Introduction (NPI) and Receiving Unit (RU) Readiness execution across the biologics network. The role leads Launch Excellence workstreams, partners with site and global stakeholders, and translates launch execution learnings into sustainable best practices, procedure updates, and standard schedule improvements to support consistent, efficient, and repeatable launch readiness while maintaining quality, safety, cost, resource, and timing objectives.

Our facility in Dunboyne is a premier, state-of-the-art facility that enables and advances our best work. By integrating leading-edge technology with a dynamic, activity-based workspace, the facility supports seamless connection and collaboration within and across teams and functions. Our Dunboyne facility provides Biologics Drug Substance manufacturing for Clinical Supply, Registration, and Commercial Launch.

Responsibilities

• Deliver sustained and measurable improvements (through defined KPIs, leading indicators, and performance measures) to key business processes required for the execution of NPI and RU Readiness.
• Drive effective alignment with global and local stakeholders and all involved departments to develop truly holistic improvement concepts.
• Lead one or more cross-functional sub-teams within the GBO “Launch Excellence” to advance prioritized improvement initiatives.
• Apply MPS problem-solving techniques, including structured root cause analysis, A3 thinking, PDCA, Kaizen, and other continuous improvement tools to resolve complex business process and launch readiness challenges.
• Transform lessons learned from RU Readiness execution into actionable improvement opportunities and scalable best practices.
• Integrate improvement concepts into written procedures, standards, best practices, or other controlled documentation to support sustainable implementation by Launch Readiness Leaders.
• Partner with the Launch Project Scheduling group to translate improvement opportunities into changes to standard schedule blocks, including timing assumptions and resource requirements.
• Represent launch excellence activities in relevant Site Leadership or GBO Governance meetings and in any required escalation or issue-resolution meetings.

General Competencies

• Strong leadership and interpersonal skills with the ability to manage through influence in a matrixed environment.
• Strong stakeholder management capabilities to foster alignment and enable holistic implementation of solutions across sites and functions.
• Strong ownership, sense of urgency, and willingness to escalate and proactively resolve issues.
• Proven ability to lead and collaborate within cross-functional teams.
• Ability to influence across organizational levels and work effectively with internal and external partners.
• Excellent communication skills with a strong commitment to execution discipline and delivery of results.
• Strong change management, conflict resolution, negotiation, and project management skills.
• Good business acumen and ability to make clear recommendations in the face of ambiguity.
• Collaborative mindset with a strong focus on internal customers and enterprise-wide outcomes.
• Skilled facilitation of MPS problem-solving workshops and cross-functional improvement sessions.
• Results-oriented mindset with strong ownership, accountability, urgency, and follow-through.
• Demonstrate candor and courage, make rapid disciplined decisions, drives results, and act with ethics and integrity.

Technical Competencies

• Considerable experience and critical skills in a relevant area of expertise that add value to the business; ideally in manufacturing and commercialisation of NPI, preferably in a GMP setting.
• Knowledge of cGMP and GDP preferred.
• Good working knowledge of current business processes for launch excellence and the underlying quality systems.
• Basic knowledge of aseptic processing, drug substance and/or drug product manufacturing, formulation, and filling of biologics required.
• Experience in process technology transfers and process validation required.
• Technical writing skills i.e., reports, standards, and policy writing skills required.
• Proficiency in Microsoft Office and job-related computer applications required.
• Lean Six Sigma methodology experience preferred.

Education & Experience

• Minimum of 8 years of experience in the pharmaceutical, biotechnology, or biologics manufacturing industry with at least 4 years of demonstrated leadership experience leading in a cross-functional manufacturing or launch-related environment.
• Demonstrated experience supporting New Product Introduction, Technology Transfer, Launch Readiness, Commercialization, Manufacturing Excellence, or Operational Excellence programs.
• Bachelor’s degree required, or higher preferred, ideally in a technical discipline related to pharmaceutical process development or manufacturing.

We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world’s most challenging healthcare needs. So, if you are ready to: Invent solutions to meet unmet healthcare needs, Impact the future by driving one of the world’s leading healthcare companies, and inspire your team to reach their full potential and push the boundaries of science and technology, please apply today.

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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.

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