Associate Director NPI

Morgan McKinley; Ballina; On-site; EUR 120,000 - 180,000; Full time

Job summary

Morgan McKinley is recruiting an experienced NPI and Technical Operations leader for a premier biologics manufacturing site in the West of Ireland. You will own all New Product Introduction programmes, drive technology transfers, regulatory readiness and manufacturing collaborations to bring innovative biologics to market.

You will lead a multidisciplinary team, optimise processes, manage transfers end-to-end, oversee quality and compliance, and partner with Quality, Validation, Manufacturing,

Qualifications

• MSc (or higher) in Engineering, Biotechnology, Pharmaceutical Sciences, Chemistry, or a related scientific discipline.
• Significant experience in biologics manufacturing, process engineering, technical operations, process development, or new product introduction within a regulated pharmaceutical environment.
• Demonstrated experience leading technology transfer and NPI programmes from development through commercialisation.
• Proven people leadership experience managing technical teams, including engineers and scientists.

Responsibilities

• Lead and develop a team of technical professionals responsible for New Product Introduction activities across the site.
• Manage end-to-end drug product technology transfers into commercial manufacturing, including project delivery, timelines, budgets, and stakeholder management.
• Provide technical leadership and support for both commercial operations and new product launches, addressing production issues, investigations, deviations, and process improvements.
• Drive continuous improvement initiatives to enhance process robustness, efficiency, quality, and productivity.
• Collaborate with cross‑functional teams including Quality, Validation, Manufacturing, Engineering, R&D, Supply Chain, and EHS to ensure successful project execution.
• Lead technical assessments and implementation of manufacturing changes, including equipment upgrades, process modifications, supplier changes, and validation activities.
• Analyse process data using statistical methodologies to support decision‑making and continuous improvement programmes.
• Evaluate emerging technologies and identify opportunities for innovation and operational enhancement.
• Support global technical initiatives and ensure alignment with site and corporate objectives.
• Maintain compliance with all regulatory, quality, environmental, health and safety requirements.

Skills

Leadership

Regulatory compliance

Project management

GMP manufacturing

Analytical thinking

Education

MSc in Engineering or related field

Tools

Statistical analysis

Job description

An exciting opportunity has arisen for an experienced NPI and Technical Operations leader to join a world-class biologics manufacturing facility in the West of Ireland. Reporting to the senior site leadership team, this role will take ownership of all New Product Introduction (NPI) programmes on site, ensuring successful technology transfers, commercial readiness, process optimisation, and regulatory compliance. The successful candidate will lead a multidisciplinary technical team and play a key role in bringing innovative biologic products to market while supporting operational excellence across manufacturing.

Key Responsibilities

Lead and develop a team of technical professionals responsible for New Product Introduction activities across the site. Manage end-to-end drug product technology transfers into commercial manufacturing, including project delivery, timelines, budgets, and stakeholder management. Provide technical leadership and support for both commercial operations and new product launches, addressing production issues, investigations, deviations, and process improvements. Drive continuous improvement initiatives to enhance process robustness, efficiency, quality, and productivity. Collaborate with cross‑functional teams including Quality, Validation, Manufacturing, Engineering, R&D, Supply Chain, and EHS to ensure successful project execution. Lead technical assessments and implementation of manufacturing changes, including equipment upgrades, process modifications, supplier changes, and validation activities. Analyse process data using statistical methodologies to support decision‑making and continuous improvement programmes. Evaluate emerging technologies and identify opportunities for innovation and operational enhancement. Support global technical initiatives and ensure alignment with site and corporate objectives. Maintain compliance with all regulatory, quality, environmental, health and safety requirements.

Candidate Profile

MSc (or higher) in Engineering, Biotechnology, Pharmaceutical Sciences, Chemistry, or a related scientific discipline. Significant experience in biologics manufacturing, process engineering, technical operations, process development, or new product introduction within a regulated pharmaceutical environment. Demonstrated experience leading technology transfer and NPI programmes from development through commercialisation. Proven people leadership experience managing technical teams, including engineers and scientists. Strong understanding of GMP manufacturing, validation requirements, and regulatory expectations. Experience supporting regulatory submissions, inspections, and health authority audits. Excellent analytical, problem‑solving, communication, and stakeholder management skills. Strong project management capabilities with the ability to influence and drive decision‑making across multiple functions and leadership levels.

Skills: NPI TPBN1_IJ