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Associate Director, Downstream Technical Operations Lead
Posted 11 hours 58 minutes ago by Merck Gruppe - MSD Sharp & Dohme
Job Description
Join our state-of-the-art biologics manufacturing facility inDunboyneas theDownstream Technical Operations Lead.
In this pivotal role, you will hold end-to-end technical, manufacturing, and people accountability for a complex, growing biologics program. Reporting directly to the Downstream Technical Operations Director as part of the MSAT function, you will lead a high-performing team of scientists and engineers delivering day-to-day manufacturing support across all downstream unit operations - including chromatography, filtration, and formulation.
What You Will Do Technical Program Ownership- Maintainend-to-end technical ownershipof the assigned biologics program, guiding activities from technology transfer and PPQ execution through to commercial lifecycle management.
- Act as a core member of the Downstream technical leadership team, helping to shape the site's overalltechnical strategy and execution standards.
- Enable robust, compliant, and reliable production by providingvisible, floor-based technical supportto resolve real-time manufacturing issues.
- Set clear priorities, expectations, and decision-making frameworks to ensure rapiddeviation investigations, root-cause analyses, and change implementation.
- Proactivelyidentify, assess, and resolvemanufacturing risks, establishing strong escalation practices and transparent communication with site and global stakeholders.
- Lead, coach, and developa team of downstream scientists, engineers, SMEs, and subteam leads, ensuring clear accountabilities, capacity management, and strong engagement.
- Foster a cultureof continuous learning, scientific rigor, engineering excellence, psychological safety, and lean-driven improvement.
- Mentor team membersthrough complex problem-solving, stretch assignments, and subteam leadership opportunities to strengthen site succession plans.
- Collaborate closely withDownstream Receiving Unit lead,Integrated Process Teams, Commercialisation partners, and the Global Biologics Organisation to align technical priorities, share best practice, and accelerate the successful delivery of a complex and evolving pipeline.
- Partner closely at the interface betweenDevelopment, Quality, Engineering, Automation, Supply Chain, and global technical partnersto drive strategic program delivery.
- Degree:B.S., M.S., or Ph.D. in a relevant Engineering or Scientific discipline.
- Experience:A minimum of 8-10 yearsof experience in biopharmaceutical manufacturing and/or development, with a proven track record in scientific and technical leadership roles.
- Downstream Processes:Deep technical expertise in biologics molecules,chromatography, filtration, formulation, process equipment, and automation.
- Product Lifecycle:Proven experience in biologics drug substance development, downstream technical operations, technology transfer, PPQ, and new product introduction.
- GMP Compliance:Strong operational experience in ahighly regulated GMP environment, including floor-based support, regulatory filings, investigations, quality notifications, CAPA management, and process monitoring.
- Business Acumen:Solid understanding of product lifecycle management, financial stewardship, and the ability to manage resource allocation across multiple complex programs simultaneously.
- Leading Through Others:Proven ability to build, scale, and lead high-performing technical teams, setting clear priorities and coaching technical decision-making.
- Stakeholder Management:Excellent communication and presentation capabilities, with a demonstrated ability to influence and collaborate across all levels of a global network.
- Agility & Drive:A strong sense of urgency, resilience, and change agility, combined with an engaging, motivational leadership style.
- Work in acutting-edge, state-of-the-art biologics facilityin Dunboyne.
- Lead a diverse, growing pipeline ofbiologics programs.
- Drive technical excellence within a highly collaborative, cross-functional global network.
Business Acumen, Business Acumen, Business Management, Change Adoption, Chromatography, Computerized Maintenance Management Systems (CMMS), Cross-Cultural Awareness, Deviation Investigations, Financial Management, GMP Compliance, GMP Environments, Maintenance Supervision, Manufacturing Quality Control, Manufacturing Support, People Leadership, Pharmaceutical Development, Process Engineering, Process Improvements, Product Lifecycle, Regulatory Compliance, Regulatory Inspections, Resource Allocation, Single-Use Systems (SUS), Sterile Manufacturing, Strategic Thinking + 1 more
Preferred Skills:Employee Status:Regular
Relocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:Hybrid
Shift:
Valid Driving License:
Hazardous Material(s):
Merck Gruppe - MSD Sharp & Dohme
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