Upstream NPI Receiving Unit Lead (AD)

Job Description An exciting opportunity has arisen for an Upstream NPI 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 upstream technical elements of multiple complex biologics TT programs at the 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 systems-level understanding of the interconnectivity between manufacturing operations and the science underpinning our products - encompassing end-to-end risks, control strategy, process characterisation, cell culture performance, and upstream process robustness. Reporting to the Director of Upstream 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

As part of the Upstream Tech Ops leadership team, you will provide strategic technical leadership and coaching to DS subteam leads working on the various TT/NPI programs and provide coaching and mentoring to other members of staff across clinical manufacturing and commercial operations of the transferred program Dunboyne site. As the technical lead for multiple complex technology transfer programs, the Receiving Unit Lead assumes full technical accountability across all phases of technology transfer for upstream - from pre-kick-off gap analysis and tech transfer readiness through GMP engineering runs, PPQ execution, regulatory filing, and launch readiness. This encompasses deep technical understanding of upstream process development and process characterisation activities, including cell line, seed train, bioreactor, media, feed strategy, process parameter, scale-up, and control strategy considerations that ensure successful manufacturability of the process. The Receiving Unit Lead provides hands on SME support during PPQ, early production, and transitions to new manufacturing nodes, and continues as an escalation point throughout commercial manufacture for multiple upstream programs across all relevant suites in Dunboyne. Responsibility extends to leading and/or supporting complex investigations - deviations, OOS/OOT events, contamination incidents - driving rigorous, data led root cause analysis, durable corrective actions, and the identification and installation of systemic improvements. Cross programme and cross site trend detection, process monitoring, technical risk reviews, and knowledge management stewardship are integral elements of the role, as is regulatory support - including RtQ responses, CMC submissions, and licence preparation and audit support. Where appropriate, the Receiving Unit Lead also assumes the Sending Unit role for post Transition to Supply technology transfers, ensuring continuity of technical knowledge across the network. Own Upstream 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, 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.

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.

Required Skills

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

Preferred Skills:

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.

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.