Are you ready to lead a complex external manufacturing network to deliver life-transforming therapies for people living with rare and devastating diseases? In this role, you will turn strategic intent into operational excellence—ensuring reliable, compliant supply while elevating performance across multiple contract manufacturing organizations.
Based in Dublin, you will be a key member of a growing External Manufacturing & Operations function, partnering closely with internal and CMO teams to uphold the highest manufacturing standards from late-stage clinical and PPQ through sustaining commercial operations. You will shape network strategy, inspection readiness, and contributions to regulatory filings—so patients receive vital medicines without delay.
Accountabilities:
CMO Partnership Leadership: Lead and direct cross-functional, tiered governance with CMOs to meet supply, quality, schedule, and budget objectives; proactively surface and resolve issues and manage risks end-to-end.
Technical Oversight: Provide deep operational and technical expertise across drug substance and drug product manufacturing at CMOs; lead troubleshooting and high-level deviation investigations with internal partners.
Governance and Alignment: Lead Local and Global Joint Steering Committee engagements, driving clear decisions and internal cross-functional alignment on priorities and trade-offs.
Process and Yield Improvement: Identify and implement initiatives that improve efficiency, yield, quality, and capacity; bring together and scale standard methodologies across the network.
End-to-End Supply Optimization: Co-develop strategies that improve success rates and flow through the value chain; partner across functions to maintain optimal months-on-hand inventory.
Network Strategy and COGs: Provide strategic operational input to network decisions (including CMO selection and S&OP) and partner with Finance to deliver and track cost-of-goods reduction plans.
Risk-Based Oversight Model: Build and deploy a right-sized oversight approach with CMO partners to focus attention where it creates the most value as the portfolio grows.
Regulatory and Inspection Excellence: Drive perfection in PAI and routine cGMP inspections; provide SME input for IND, BLA, and other regulatory submissions supporting CMO-operated processes.
Travel and Site Engagement: Visit CMO sites routinely to strengthen relationships, verify performance, and accelerate issue resolution.
Immediate focus will be on stabilizing and elevating performance at current CMOs; as you demonstrate results, you will influence broader network strategy and accelerate supply resilience for a growing portfolio. How will you raise the bar on external operations and translate it into diligent supply for patients?
Essential Skills/Experience:
- Minimum of 5 years’ experience in providing operational / technical support to biologics product manufacturing
- Extensive knowledge of a variety of drug substance manufacturing platforms (such as mammalian cell culture, microbial fermentation, small molecules, peptides, oligonucleotides, etc.), drug product and finished product
- Comprehensive understanding of cGMP requirements for clinical and commercial manufacturing
- Ability to present and defend technical aspects of manufacturing operations during regulatory agency inspections
- Demonstrated experience with technology transfers and scale-up of manufacturing processes
- Experience of working with CMOs demonstrating strong communication and influencing skills
- Ability to demonstrate strategic thinking and risk management - Systems and process development, optimization and implementation
- Minimum BS degree in Scientific (Biochemistry, Biology, Chemistry) or Engineering (Chemical, Mechanical) related field
Desirable Skills/Experience:
- Advanced degree in a relevant Scientific or Engineering discipline - Experience leading governance with external manufacturers (local/global steering committees)
- Demonstrated success…