Strategic Development & Commercialization Lead

Strategic Development & Commercialization Lead

A Strategic Development & Commercialization Lead is required by CareerWise Recruitment for our Galway based client. The role bridges four key technical pillars: Operations, Quality, Manufacturing Science & Technology (MS&T) and Engineering, and involves leading the execution of a critical 3 year commercialization program for a new sterile product filling line.

Responsibilities

• Lead overall strategy and execution of the program from development through to commercialization.
• Establish and maintain a clear roadmap aligned with organizational priorities and regulatory compliance (GMP, Annex1, data integrity, sterility).
• 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 evaluating 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.
• Provide monthly progress updates to executive steering committees.
• Ensure deliverables meet customer, regulatory, and business expectations.
• Oversee facility, new process equipment, and process modifications as needed for adaptation of the facility for the new product.
• Implement lean manufacturing workflows to optimize cycle times post launch.

Qualifications

• 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 - 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 ability to embed these into program execution and decision making.
• Strong risk management and decision making capabilities.
• Exceptional stakeholder management and communication skills.