Technical Manager - ADC
- Sligo
- Permanent
- Full-time
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. Looking for somebody who is experienced working with Antibody Drug Conjugates.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.
- MSc in Chemistry, Biochemistry, Chemical Engineering, or a related discipline.
- A minimum of 5 years of experience in the pharmaceutical or biotechnology industry.
- A minimum of one year of experience working with Antibody Drug Conjugates
- Knowledge of clinical and commercial manufacturing processes, CMC (Chemistry, Manufacturing and Controls) development, and technical lifecycle management.