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Associate Director, Downstream Technical Operations Lead

msd · IRL - Meath - Dunboyne

New
Senior 🇬🇧 English
Chromatography Filtration Formulation GMP Technology Transfer PPQ CAPA Single-Use Systems CMMS

Job description

About the role

MSD is looking for an Associate Director, Downstream Technical Operations Lead to join its biologics manufacturing facility in Dunboyne. 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 team of scientists and engineers delivering day-to-day manufacturing support across chromatography, filtration and formulation.

Key responsibilities

  • Maintain end-to-end technical ownership of the assigned biologics program, from technology transfer and PPQ execution through to commercial lifecycle management.
  • Act as a core member of the Downstream technical leadership team, shaping the site's technical strategy and execution standards.
  • Provide visible, floor-based technical support to resolve real-time manufacturing issues, set priorities and decision-making frameworks for deviation investigations, root-cause analyses and change implementation, and proactively identify and escalate manufacturing risks.
  • Lead, coach and develop a team of downstream scientists, engineers, SMEs and subteam leads, fostering continuous learning, scientific rigor, engineering excellence, psychological safety and lean-driven improvement.
  • Collaborate with the Downstream Receiving Unit lead, Integrated Process Teams, Commercialisation partners and the Global Biologics Organisation, and partner with Development, Quality, Engineering, Automation, Supply Chain and global technical partners.

Required profile

  • Degree (B.S., M.S. or Ph.D.) in a relevant Engineering or Scientific discipline.
  • Minimum 8-10 years of experience in biopharmaceutical manufacturing and/or development, with a track record in scientific and technical leadership roles.
  • Proven ability to build and lead high-performing technical teams, communicate and present effectively, and work across a global network.

Required skills

  • Biologics drug substance development, downstream technical operations, technology transfer, PPQ and new product introduction.
  • GMP compliance, including regulatory filings, investigations, quality notifications, CAPA management and process monitoring.
  • Chromatography, filtration, formulation, process equipment and automation.
  • Business acumen, resource allocation across multiple programs and stakeholder management.

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Source : ats:workday

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Published 11 hours ago

Expires 1 month from now

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msd

IRL - Meath - Dunboyne