Job Title:
Technical Manager - New Product Introduction (NPI)
Location:
Sligo, Ireland
Overview:
An advanced pharmaceutical manufacturing site specializing in precision high-volume moulding, auto-assembly, and aseptic fill-finish operations is seeking a Technical Manager to lead and support New Product Introductions (NPIs) across multiple departments. This role offers the opportunity to drive innovation and operational excellence during a time of significant growth and development.
The successful candidate will report to the Technical Operations Manager and provide technical leadership across NPI product, process, and project teams.
Key Responsibilities:
- Lead and manage the introduction of new products, processes, and technologies from early-stage development through to process performance qualification (PPQ).
- Coordinate cross-functional teams across technical, manufacturing, quality, supply chain, and external manufacturing functions to deliver NPI goals.
- Conduct comprehensive site-fit assessments for new product pipeline and external opportunities.
- Oversee and coordinate technical support for NPIs across the full biologics manufacturing area.
- Ensure alignment with internal and external program management teams on schedules and deliverables.
- Drive resource planning and ensure appropriate technical support is in place for all NPI activities.
- Foster a culture of innovation and continuous improvement within the function.
- Provide mentorship and leadership to cross-functional teams during NPI execution.
- Act as a key technical liaison with external partners to support effective process design and control strategies.
- Generate and approve documentation supporting product transfer, ensuring all technical deliverables are met before key project milestones.
- Support compliance with current Good Manufacturing Practices (cGMP) and environmental, health and safety (EHS) standards.
- Participate in formal gate reviews for NPI projects and serve as a subject matter expert (SME) during regulatory inspections and internal audits.
Required Qualifications:
- Degree in Chemistry, Biochemistry, Chemical Engineering, or a related discipline.
- A minimum of 8 years of experience in the pharmaceutical or biotechnology industry.
- Demonstrated strategic leadership experience with the ability to motivate and lead cross-functional and global teams.
- Knowledge of clinical and commercial manufacturing processes, CMC (Chemistry, Manufacturing and Controls) development, and technical lifecycle management.
- Strong understanding of regulatory and quality frameworks relevant to product development and commercialization.
