Science and Technology Lead

Uniting Holding; Loughrea; On-site; EUR 60,000 - 80,000; Full time

Job summary

A pharmaceutical manufacturing company is seeking a Science & Technology Support Leader in Loughrea. The role involves providing technical leadership and scientific expertise in manufacturing, supporting process improvements, technology transfer, and ensuring compliance with regulatory requirements. Ideal candidates should have a degree in a related field and at least 8-10 years of experience in pharmaceutical manufacturing or technical services.

Qualifications

• Minimum 8–10 years’ experience in pharmaceutical manufacturing or process development.
• In-depth understanding of GMP, ICH Q8–Q12 guidelines, and regulatory expectations.
• Experience working in both sterile and non-sterile environments is advantageous.

Responsibilities

• Provide technical oversight and scientific guidance to manufacturing operations.
• Lead technology transfer of new products and scale-up processes.
• Identify and deliver process improvements to enhance yield and product quality.

Skills

Process validation

Technical leadership

Data analysis

Regulatory compliance

Problem-solving

Team leadership

Communication

Education

Bachelor’s or Master’s degree in Pharmaceutical Science, Chemical Engineering, Biotechnology

Tools

JMP

Minitab

Excel

Job description

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 S&T Leader acts as a key technical interface between R&D, 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 R&D 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 S&T 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.