Biologics Upstream NPI Lead - Tech Transfer & Scale-Up

MSD Ireland; Dunboyne; Hybrid; EUR 150,000 - 210,000; Full time

Benefits offered by this job

Hybrid work arrangement

Job summary

MSD Ireland is seeking an Upstream NPI Receiving Unit Lead to own end-to-end upstream technical elements for multiple biologics TT programs at our Dunboyne site. You will drive technical excellence from late-stage development through PPQ and scale-up, coordinating across TT/NPI programs and regulatory activities.

The role requires a PhD/MS/BS in a scientific discipline and at least 6 years of biopharma experience, with strong leadership, GMP, and cross-site collaboration capabilities to ensure

Qualifications

• B.S., M.S., or Ph.D. in a relevant Engineering or Scientific discipline.
• A minimum of 6 years’ experience within biopharmaceutical manufacturing and/or development, with a strong emphasis on scientific and technical leadership roles.
• Demonstrated technical excellence with deep expertise in biologics molecules, upstream manufacturing processes, cell culture, bioreactor operations, process equipment, and automation.
• Proven experience in biologics drug substance development, commercialisation, control strategy development, technical operations, and new product introduction.
• Strong communication, presentation, and stakeholder-management capabilities, with the ability to influence at all levels of the organization.
• A track record of effective cross-divisional collaboration and matrix leadership.
• Experience operating within a GMP manufacturing environment, including regulatory filings, investigations, quality notifications, and CAPA management.
• Solid business acumen, including an understanding of product lifecycle management, financial stewardship, and the ability to manage multiple complex programs simultaneously.
• A strong sense of urgency, resilience, and change agility, combined with an engaging and motivational leadership style.

Responsibilities

• Provide strategic technical leadership to DS subteam leads on TT/NPI programs.
• Own full technical accountability across phases of technology transfer for upstream.
• Oversee upstream process development, cell culture, bioreactor operations, and scale-up considerations.
• Offer SME support during PPQ, early production, and transitions to new manufacturing nodes.
• Lead investigations and drive durable corrective actions for deviations and CAPA.
• Support regulatory filings, RtQ responses, and licence preparation.

Skills

Drug Product Development

GMP Compliance

Manufacturing Operations

New Product Introduction (NPI)

Pharmaceutical Process Development

Process Optimization

Product Introduction

Safety Compliance

Technology Transfer

Education

B.S., M.S., or Ph.D. in a relevant Engineering or Scientific discipline

Job description

MSD Ireland is seeking an Upstream NPI Receiving Unit Lead to own end-to-end upstream technical elements for multiple biologics TT programs at our Dunboyne site. You will drive technical excellence from late-stage development through PPQ and scale-up, coordinating across TT/NPI programs and regulatory activities.

The role requires a PhD/MS/BS in a scientific discipline and at least 6 years of biopharma experience, with strong leadership, GMP, and cross-site collaboration capabilities to ensure