Downstream NPI Receiving Unit Lead (AD)

MSD Ireland; Dunboyne; Hybrid; EUR 110,000 - 150,000; Full time

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

Job Description

An exciting opportunity has arisen for a Downstream New Product Introduction Receiving Unit Lead (AD) to join our new state–of–the–art single–use Multiproduct Biotech facility in Dunboyne. The successful candidate will be a highly skilled technical subject matter expert with end-to-end ownership of the downstream technical elements of multiple complex biologics TT programs at Dunboyne site. Serving as the single point of receiving unit accountability for New Product Introduction (NPI) and Technology Transfer activities, this individual brings deep scientific expertise, problem solving and a system-level understanding of the interconnectivity between manufacturing operations and the science underpinning our products — encompassing end-to-end risks, control strategy, and process characterisation. Reporting to the Director of Downstream Technical Operations, the Receiving Unit Lead drives technical excellence across all commercialisation stages of multiple programs — from late–stage development and NPI through engineering runs, process validation, PPQ execution, commercial scale–up, and multi–site sustainment. This role is pivotal to the successful, right–first–time commercialisation of a diverse and increasingly complex biologics pipeline, ensuring robust, compliant, and reliable manufacture of high–quality biologics for patients.

Our facility in Dunboyne joined our network in September 2020. Our Dunboyne site is our Company’s first Biologics Drug Substance Single Use Commercialisation Facility, playing a significant role in helping to commercialise key medicines. The innovation and collaboration between our Company’s research and manufacturing teams will significantly accelerate the time it takes to bring a medicine to market for the benefit of patients around the world.

Responsibilities

• Provide strategic technical leadership and coaching to DS subteam leads working on various TT/NPI programs and offer mentorship to staff across clinical manufacturing and commercial operations at the Dunboyne site.
• Assume full technical accountability across all phases of technology transfer for downstream — from pre–kick–off gap analysis and tech transfer readiness through GMP engineering runs, PPQ execution, regulatory filing, and launch readiness.
• Apply deep technical understanding of process development and process characterisation activities to develop robust control strategies that ensure successful manufacturability.
• Provide hands–on SME support during PPQ, early production, and transitions to new manufacturing nodes, continuing as an escalation point throughout commercial manufacture across all suites in Dunboyne.
• Lead and support complex investigations — including deviations, OOS/OOT events, and contamination incidents — driving rigorous, data–led root cause analysis, durable corrective actions, and systemic improvements.
• Oversee cross–programme and cross–site trend detection, process monitoring, technical risk reviews, and knowledge management stewardship, while providing robust regulatory support (RtQ responses, CMC submissions, and licence preparation.
• Assume the Sending Unit role, where appropriate, for post–Transition–to–Supply technology transfers, ensuring seamless continuity of technical knowledge across the network.
• Own Downstream technical lifecycle management for in–line commercial products, driving continuous improvement, robustness, and process sustainability.

Skills & 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, Downstream manufacturing processes, process equipment, and automation.
• Proven experience in biologics drug substance 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.

We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world’s most challenging healthcare needs. So, if you are ready to: Invent solutions to meet unmet healthcare needs, Impact the future by driving one of the world’s leading healthcare companies, and inspire your team to reach their full potential and push the boundaries of science and technology, please apply today.

Required Skills

GMP Compliance, Manufacturing Operations, New Product Introduction (NPI), Pharmaceutical Process Development, Process Development (PD), Process Optimization, Product Introduction, Safety Compliance, Technology Transfer

Preferred Skills

Downstream Manufacturing

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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. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status

Regular

Relocation

VISA Sponsorship

Travel Requirements

Flexible Work Arrangements

Hybrid

Shift

Valid Driving License

Hazardous Material(s)

Job Posting End Date

09/5/2026

• A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID:

R410685