Job Description
We have an exciting opportunity for a Director, Drug Substance Commercialisation & Development for our site in Ballydine, Co. Tipperary. The successful candidate will provide strategic and technical leadership for the introduction, development, and commercial manufacture of clinical and commercial active pharmaceutical ingredients (APIs).
This role carries end to end accountability for Drug Substance commercialisation activities at Ballydine, including process development, scale up, validation, and lifecycle management. The Director will ensure safe, compliant, and robust supply while driving continuous improvement, capability development, and alignment with enterprise objectives.
Ballydine is the primary Drug Substance commercialisation hub within the network, where new processes are scaled and transitioned to commercial manufacture. The site supports clinical and commercial API supply and the transfer of processes and technologies across internal manufacturing sites and external partners.
Key Responsibilities
Strategic & Functional Leadership
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As a member of the Commercialisation Leadership Team, define, own, and implement the Drug Substance commercialisation strategy for the site and assigned portfolio.
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Provide senior technical authority for API commercialisation decisions impacting safety, quality, regulatory compliance, cost, timelines, and supply reliability.
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Lead technical support for commercialisation activities across multiple clinical and commercial processes, ensuring alignment with product and portfolio strategies.
Process Development & Commercialisation
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Direct process development, optimisation, and scale up activities, including evaluation of raw materials, route selection, and process fit for commercial manufacture.
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Provide leadership for pre-PPQ, PPQ, and commercial production campaigns, ensuring robust process performance and operational readiness.
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Approve campaign preparation and follow up activities, including safety and environmental assessments, batch records, validation strategies, and regulatory compliance.
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Oversee process monitoring, cycle time analysis, deviation investigations, and definition of cleaning and control strategies.
Technical Oversight & Risk Management
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Direct chemistry and engineering support for new and existing clinical and commercial processes, evaluating scale up, plant operability, EHS, and sustainability impacts.
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Proactively identify, assess, and mitigate technical, operational, and supply risks, escalating and resolving issues at an enterprise level when required.
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Ensure laboratory and manufacturing activities are conducted safely and in compliance with cGMP, GLP, and corporate standards.
Network & External Engagement
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Lead and govern transfers of Drug Substance processes to internal sites and external manufacturing partners.
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Act as a senior technical interface with external partners, regulators, and auditors, supporting submissions, inspections, and technical exchanges.
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Ensure assigned processes and systems meet site, divisional, and corporate quality standards and support regulatory and customer commitments.
People, Capability & Business Leadership
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Lead, develop, and inspire a team of technical leaders and specialists; build organization capability, succession plans, and technical depth.
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Delegate with clear accountability, provide coaching and feedback, and create growth opportunities across technical and leadership dimensions.
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Contribute to resource planning, budget management, R&D tax reporting, and departmental administration as part of the Technical Leadership Team.
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recruitment, assessment, and development programs, and actively shape site people and organizational development strategies.
Core Competencies & Functional Leadership
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Recognized subject matter expert in Drug Substance process development and commercialisation.
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Strong understanding of CMC strategy, late-stage development, and product lifecycle management.
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Ability to synthesize complex technical data and influence senior program and portfolio decisions.
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Drives execution through others, translating strategy into clear priorities, governance, and accountability.
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Anticipates challenges, escalates risks effectively, and delivers pragmatic, compliant solutions.
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Understands interdependencies across clinical development, CMC, manufacturing, and supply chain to enable successful launches and stable supply.
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Communicates with clarity and authority, building trust and alignment across cross functional and external stakeholders.
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Champions innovation, continuous improvement, and alternative approaches to achieve business and technical outcomes.
Your profile
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Degree (BSc/BEng/Masters) or higher (PhD) in Chemistry/Pharmacy or Chemical/Process Engineering.
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Experience (Min 15 yrs) in process chemistry, chemical engineering, and API commercial manufacture.
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Strong background in process, equipment, and cleaning validation.
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In depth knowledge of cGMP manufacturing operations and regulatory expectations.
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Experience with electronic batch records and control systems (e.g., DeltaV).
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Proven capability in deviation management, inspection readiness, and regulatory interactions.
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Demonstrated experience in financial management, budgeting, and resource planning.
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Knowledge of HR processes, training systems, process safety management, and environmental compliance.
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Excellent written, verbal, and executive level communication skills.
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Strong cross functional leadership, strategic thinking, project execution, and lean / continuous improvement mindset.
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. 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 ideas come together in an inclusive environment.
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.
Required Skills:
Capital Management, Change Management, Chemical Engineering, Cross-Cultural Awareness, Cross-Functional Leadership, Decision Making, Financial Management, GMP Compliance, Innovation, Organizational Development (OD), Process Improvements, Product Lifecycle, Results-Oriented, Safety Management, Strategic Thinking, Technical Leadership
Preferred Skills:
Manufacturing
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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.
Employee Status:
Regular
Relocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Hybrid
Shift:
Valid Driving License:
Hazardous Material(s):
Job Posting End Date:
05/22/2026
- 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:R394934
