Strategic Development & Commercialization Lead

A Strategic Development & Commercialization Lead is required by CareerWise Recruitment for our Galway based client. As the Strategic Development & Commercialization Lead, you will lead the execution of a critical, 3-year commercialization program for a new Sterile product filling product line. This role bridges four key technical pillars: Operations, Quality, Manufacturing Science & Technology (MS&T) and Engineering. The Strategic Development & Commercialization Lead will drive the project from late-stage development through process validation, equipment qualification, and commercial readiness.

THE ROLE:

• Lead the overall strategy and execution of the program from development through to commercialization
• Establish and maintain a clear roadmap, ensuring alignment with organizational priorities and that regulatory compliance (GMP, Annex 1, data integrity) and sterility requirements are met
• Drive delivery against key milestones, timelines, and success metrics
• Lead core project teams across Operations, Quality, MS&T, and Engineering
• Implement robust program governance structures, including regular reviews and reporting
• Proactively identify, assess, and manage risks, ensuring mitigation plans are in place and evaluate impact on existing products (multiproduct contamination control strategy)
• Ensure informed decision-making through clear visibility of risks, dependencies, and trade- offs
• Partner with commercial and operational teams to ensure a successful and sustainable launch and provide monthly progress updates to executive steering committees
• Ensure that deliverables meet customer, regulatory, and business expectations
• Oversee facility, new process equipment and process modifications as needed for the adaptation of the facility for the new product
• Implement lean manufacturing workflows to optimize cycle times post-launch

REQUIREMENTS:

• Bachelor’s Degree in Engineering, Life Sciences, or a related discipline
• Master’s degree such as MBA (Master of Business Administration) or MSc in Engineering, Project Management, or a relevant technical field a distinct advantage
• Project Management Professional (PMP) or equivalent
• Lean Six Sigma (Green Belt or Black Belt)
• Proven experience leading complex, multi-year program or large-scale projects
• Ability to lead cross-functional teams, with 10+ years management experience
• Demonstrated success in bringing products/processes from development to commercialization
• Experience working within cross-functional, matrixed organizations
• Excellent program and project management skills
• Extensive knowledge of regulatory compliance, including GMP requirements, data integrity, and expectations of key regulatory bodies, with the ability to embed these into program execution and decision-making
• Strong risk management and decision-making capabilities
• Exceptional stakeholder management and communication skills