Senior Analytical Scientist

Morgan McKinley; Leinster; On-site; EUR 65,000 - 90,000; Full time

Job summary

Morgan McKinley is seeking a Senior Analytical Scientist to join the Commercial Product Characterisation team within Process Development. The role focuses on forensic investigation, defect analysis, and curating defect libraries for sterile injectable products including liquid vials, lyophilised vials, and pre-filled syringes.

The ideal candidate will combine rigorous analytical work with a strong understanding of cGMP, data integrity, and visual inspection systems, while mentoring junior team

Qualifications

• Bachelor's degree in Analytical Chemistry, Biochemistry, Forensic Science, or related scientific discipline.
• 3–6 years of hands-on technical experience in a regulated cGMP pharmaceutical or biopharmaceutical environment.
• Experience in analytical method development, validation and troubleshooting; familiarity with statistical tools for root-cause analysis.

Responsibilities

• Lead and support laboratory-based investigations into physical, particulate, and cosmetic defects in drug product manufacturing; author technical investigation reports aligned with cGMP.
• Oversee curation, qualification, tracking, and maintenance of physical defect panels for visual inspection systems.

Skills

Analytical problem solving

Documentation & communication

Mentoring junior staff

Education

Bachelor's degree in Analytical Chemistry / Biochemistry / Forensic Science

Job description

Senior Analytical Scientist - Product Forensics & Defect Characterisation

Position Overview

A leading biopharmaceutical manufacturing organisation is seeking a Senior Analytical Scientist to join the Commercial Product Characterisation team within Process Development.

This role focuses on forensic investigation, root-cause defect analysis, and the curation of inspection defect libraries across sterile injectable product lines (liquid vials, lyophilised vials, and pre-filled syringes). The ideal candidate will combine rigorous analytical investigation with a robust understanding of cGMP, data integrity, and visual inspection systems.

Key Responsibilities

• Forensic & Defect Investigation: Lead and support laboratory-based investigations into physical, particulate, and cosmetic defects occurring during drug product manufacturing; author comprehensive technical investigation reports aligned with cGMP standards.
• Defect Panel Management: Oversee the curation, qualification, tracking, and maintenance of physical defect panels utilised in the setup, qualification, and routine operation of automated, semi-automated, and manual visual inspection systems.
• Cross-Functional Collaboration: Act as the subject matter expert representing the analytical characterisation function on multi-disciplinary operational and project teams.
• Data Integrity & Documentation: Maintain detailed, compliant records of all analytical activities within Electronic Lab Notebook (ELN) systems, adhering to strict data integrity standards; conduct thorough peer reviews of analytical datasets.
• Laboratory Compliance & Safety: Uphold Standard Operating Procedures (SOPs), environmental health and safety standards, and sustainable lab practices.
• Quality & Deviations: Drive timely closure of laboratory investigations, deviations, and post-marketing change evaluations.
• Audits & Continuous Improvement: Participate in internal quality audits and external regulatory agency inspections; identify and implement workflow enhancements to streamline testing throughput and lab productivity.

Core Qualifications & Experience

• Education: Bachelor's degree (or equivalent third-level qualification) in Analytical Chemistry, Biochemistry, Forensic Science, or a related scientific discipline.
• Experience: 3-6 years of hands-on technical experience within a regulated cGMP pharmaceutical or biopharmaceutical environment.
• Technical Expertise: Demonstrated background in analytical method development, validation, and troubleshooting, alongside familiarity with statistical analysis tools (e.g., multivariate analysis) for root-cause problem solving.
• Regulatory Acumen: Solid understanding of quality management systems, change control, and regulatory audit readiness (prior exposure to regulatory agency audits preferred).
• Interpersonal Skills: Strong written and verbal communication, structured problem-solving capability, stakeholder management, and the ability to mentor junior team members.