Downstream NPI Receiving Unit Lead (AD)

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.

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

Job Posting End Date

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.

Company Culture

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.

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.