Basic Summary:
The Science Technology Support Leader provides technical leadership and scientific expertise to support the commercial manufacturing of pharmaceutical products. This role is responsible for ensuring robust process performance, driving continuous improvement, troubleshooting technical issues, and leading technology transfer, validation, and lifecycle management activities in compliance with GMP and regulatory requirements. The ST Leader acts as a key technical interface between RD, Manufacturing, Quality, and Regulatory Affairs, ensuring product and process knowledge are maintained and applied throughout the product lifecycle.
Location: Onsite in our Loughrea Facility.
As our Science and Technology Lead, your key responsibilities will be as follows:
Technical Leadership Process Support
* Provide technical oversight and scientific guidance to manufacturing operations for both drug substance and drug product processes.
* Lead root cause investigations for process deviations, OOS/OOT results, and recurring process issues.
* Drive process robustness improvements using data-driven and risk-based methodologies (e.g., DOE, FMEA, CPV trending).
* Serve as process owner or subject matter expert (SME) for key manufacturing steps, equipment, or technologies.
Technology Transfer Validation
* Lead or support technology transfer of new products, scale-ups, and site-to-site transfers.
* Define and execute validation strategies (process validation, cleaning validation, hold time studies, etc.) in alignment with regulatory expectations (ICH Q8-Q12).
* Collaborate with RD and Quality to ensure seamless transfer of product and process knowledge.
* Develop process characterization plans, critical parameter assessments, and control strategies.
Continuous Improvement Innovation
* Identify and deliver process improvements to enhance yield, cost efficiency, and product quality.
* Implement digital tools and process analytical technology (PAT) to improve process understanding and control.
* Support lean manufacturing initiatives and implement statistical process control (SPC) and data analytics.
* Lead technical projects to support manufacturing optimization and new technology introduction.
Regulatory Compliance
* Ensure all process changes and technical reports comply with GMP, validation, and change control procedures.
* Support regulatory submissions, inspections, and customer audits by providing technical documentation and responses.
* Maintain strong knowledge of current industry guidance (FDA, EMA, ICH, PIC/S).
People Team Leadership
* Lead and develop a multidisciplinary team of scientists and technical specialists.
* Foster a culture of scientific excellence, innovation, and knowledge sharing.
* Manage workload prioritization, resource allocation, and performance development within the ST team.
* Collaborate cross-functionally to build technical capability across the site.
Key Performance Indicators (KPIs)
* Number and impact of technical deviations resolved
* Successful technology transfers and validations completed
* Process capability and CPV compliance metrics
* Improvement in yield, throughput, or cost efficiency
* Audit and inspection readiness (technical documentation quality)
* Team development and retention metrics
Education and Experience:
* Bachelor's or Master's degree in Pharmaceutical Science, Chemical Engineering, Biotechnology, or related field (PhD preferred).
* Minimum 8–10 years' experience in pharmaceutical manufacturing, technical services, or process development.
* Proven expertise in process validation, technology transfer, and root cause investigation.
* In-depth understanding of GMP, ICH Q8–Q12 guidelines, and regulatory expectations.
* Strong data analysis and problem-solving capability (e.g., JMP, Minitab, Excel, or equivalent).
* Experience working in both sterile and non-sterile environments advantageous.
* Demonstrated ability to lead teams and manage complex, cross-functional projects.
Skills and Competencies:
* Strong scientific curiosity and technical depth.
* Excellent communication and collaboration skills.
* Hands-on leader with high attention to detail and compliance.
* Results-driven, analytical, and comfortable working in fast-paced, regulated environments.
* Passion for innovation, digital tools, and continuous improvement.
Applicants from diverse backgrounds, including those returning after a career break or with transferable skills from non-traditional career paths, are encouraged to apply. We value varied experiences and are committed to fostering an inclusive environment that supports individuals with disabilities.