Executive Director, MS&T

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 

You bring the credibility, experience, and leadership presence required to operate at an enterprise level: 

• 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

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:R390867