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Associate Director, Upstream Technical Operations Lead
Posted 6 hours 30 minutes ago by MSD Malaysia
Join our state-of-the-art biologics manufacturing facility in Dunboyne as the Upstream 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 Upstream 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 the entire upstream process-from media preparation and cell culture to bioreactor operations, harvest, and process monitoring.
What You Will Do Technical Program OwnershipMaintain end-to-end technical ownership of the assigned biologics program, guiding activities from technology transfer and PPQ execution through to commercial lifecycle management. Act as a core member of the Upstream technical leadership team, helping to shape the site's overall technical strategy and execution standards.
Manufacturing Support & Operational ExcellenceEnable robust, compliant, and reliable production by providing visible, floor-based technical support to resolve real-time manufacturing issues. Set clear priorities, expectations, and decision-making frameworks to ensure rapid deviation investigations, root cause analyses, and change implementation. Proactively identify, assess, and resolve manufacturing risks, establishing strong escalation practices and transparent communication with site and global stakeholders.
People Leadership & Talent DevelopmentLead, coach, and develop a team of upstream scientists, engineers, SMEs, and subteam leads, ensuring clear accountabilities, capacity management, and strong engagement. Foster a culture of continuous learning, scientific rigor, engineering excellence, psychological safety, and lean driven improvement. Mentor team members through complex problem solving, stretch assignments, and subteam leadership opportunities to strengthen site succession plans.
Cross Functional CollaborationCollaborate closely with Downstream 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 between Development, Quality, Engineering, Automation, Supply Chain, and global technical partners to drive strategic program delivery.
What Skills You Will Need Education & Professional ExperienceDegree: B.S., M.S., or Ph.D. in a relevant Engineering or Scientific discipline.
Experience: A minimum of 8-10 years of experience in biopharmaceutical manufacturing and/or development, with a proven track record in scientific and technical leadership roles.
Technical & Operational Expertise Upstream ProcessesDeep technical expertise in biologics molecules, cell culture, seed train, bioreactor operations, media/feed strategies, harvest, process equipment, and automation.
Product LifecycleProven experience in biologics drug substance development, technology transfer, PPQ, and new product introduction.
GMP ComplianceStrong operational experience in a highly regulated GMP environment, including regulatory filings, investigations, quality notifications, CAPA management, and audit readiness.
Business AcumenSolid understanding of product lifecycle management, financial stewardship, and the ability to manage resource allocation across multiple complex programs.
Leadership & InfluenceLeading Through Others: Proven ability to build, scale, and lead high performing technical teams, setting clear priorities and coaching technical decision making.
Stakeholder ManagementExcellent communication and presentation capabilities, with a demonstrated ability to influence and collaborate across all levels of a global network.
Agility & DriveA strong sense of urgency, resilience, and change agility, combined with an engaging, motivational leadership style.
Required Skills- Business Acumen
- Business Acumen
- Business Management
- Cell Cultures
- Change Adoption
- Computerized Maintenance Management Systems (CMMS)
- Cross Cultural Awareness
- Financial Management
- GMP Compliance
- GMP Environments
- Maintenance Supervision
- Mammalian Cell Culture
- 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
Work in a cutting edge, state of the art biologics facility in Dunboyne. Lead a diverse, growing pipeline of biologics programs. Drive technical excellence within a highly collaborative, cross functional global network.
Employee Status: Regular
Relocation: VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Hybrid Shift:
Valid Driving License: Hazardous Material(s):
Job Posting End Date: 08/20/2026
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.
Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
MSD Malaysia
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