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
Please call Tom Devaney for further information on 091-758771 or email: tdevaney@careerwise.ie
CareerWise Recruitment (In Search of Excellence)
Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the Pharmaceuticals, Life Sciences, ICT, Engineering, Food and Agri Sectors.
We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin.
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