Downstream NPI Lead: Receiving & Tech Transfer

MSD Ireland

Dunboyne

Hybrid

EUR 110,000 - 150,000

Full time

7 days ago

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Job summary

MSD Ireland seeks a Downstream New Product Introduction Receiving Unit Lead for our Dunboyne biotech facility. You will own downstream tech transfer, NPI programs, and PPQ across multiple biologics, driving end-to-end readiness and robust control strategies.

Reporting to the Director of Downstream Technical Operations, you will lead cross-functional teams, guide investigations, and ensure compliant, scalable manufacturing for patients worldwide.

Qualifications

GMP and regulatory-driven manufacturing experience required.
Expertise in downstream bioprocess development and tech transfer.
Leadership and cross-functional collaboration skills.

Responsibilities

Provide strategic technical leadership to DS subteams on TT/NPI projects.
Own technology transfer across downstream phases from gap analysis to PPQ.
Develop robust control strategies ensuring manufacturability.
Provide hands-on SME support during PPQ and early production.
Lead investigations with root cause analyses and corrective actions.
Oversee cross-program trend detection and regulatory support.
Own downstream lifecycle management for in-line products.

Skills

GMP Compliance

Manufacturing Operations

New Product Introduction (NPI)

Pharmaceutical Process Development

Process Development

Process Optimization

Product Introduction

Safety Compliance

Technology Transfer

Downstream Manufacturing

Education

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

Job description

Reporting to the Director of Downstream Technical Operations, you will lead cross-functional teams, guide investigations, and ensure compliant, scalable manufacturing for patients worldwide.

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