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.
