Senior Laboratory Associate

Ascend Project Management, Inc.; South Dublin; On-site; EUR 45,000 - 65,000; Full time

Job summary

Ascend Project Management, Inc. is seeking a Senior Lab Associate on a 12-month independent contractor basis to support forensic investigations and defect identification in pharmaceutical manufacturing.

The role focuses on finished drug product defects and maintenance of defect panels for inspection systems. Based onsite in South Dublin, Ireland, four days a week, with duties ensuring data integrity and regulatory compliance.

Qualifications

• Third-level degree in Analytical Chemistry, Biochemistry or related scientific discipline.
• Experience in forensic investigations, defect identification and analytical method development.
• Knowledge of cGMP, data integrity principles and regulatory compliance.

Responsibilities

• Lead and support forensic investigations into defects during drug product manufacturing, documenting findings per cGMP requirements.
• Maintain and distribute defect panels for equipment setup, training and characterization of visual inspection systems for finished drug products.
• Document analytical data in electronic laboratory notebook systems, ensuring data integrity and peer review.

Skills

Forensic investigations

Defect identification

Analytical data review

cGMP compliance

Data integrity

Regulatory compliance

Troubleshooting

Change control

Statistical tools

Cross-functional collaboration

Education

Analytical Chemistry / Biochemistry degree

Job description

We are working with a leading life sciences company to recruit a Senior Lab Associate to join a Commercial Attribute Sciences team. This person will support forensic investigations and defect identification within pharmaceutical manufacturing. The role will focus on identifying and investigating finished drug product defects and maintaining defect panels used to support automated, semi-automated and manual visual inspection of vial and syringe products. The successful candidate will contribute to laboratory investigations, analytical data review and the maintenance of high standards of cGMP, data integrity and regulatory compliance.

This is a 12-month independent contractor position, and candidates must have the full legal right to work in Ireland as an independent contractor.

This role is based onsite 4 days a week in South Dublin.

Key Responsibilities

• Lead and support forensic investigations into defects arising during pharmaceutical drug product manufacturing, ensuring findings are documented in accordance with cGMP requirements.
• Maintain, manage and distribute defect panels used for equipment set-up, training and characterisation of automated, semi-automated and manual visual inspection systems for finished drug products.
• Document analytical data accurately and promptly in electronic laboratory notebook systems, ensuring compliance with data integrity principles and participating in peer review activities.
• Ensure compliance with laboratory SOPs, applicable GMP requirements, training obligations and relevant quality systems, including the timely completion of investigations, deviations and associated documentation.
• Support cross-functional teams and contribute to laboratory efficiency, continuous improvement initiatives, audit and inspection readiness, and effective planning and delivery against departmental objectives.
• Maintain high standards of laboratory safety, environmental responsibility, housekeeping and inventory control, while contributing to sustainability initiatives and the continuous improvement of laboratory processes.

Key Requirements

• A minimum of a third-level degree in Analytical Chemistry, Biochemistry or a related scientific discipline.
• Approximately 3–6 years of relevant experience within the pharmaceutical industry, ideally in a laboratory, quality or pharmaceutical manufacturing environment.
• Experience in forensic investigations, defect identification, analytical method development, validation and troubleshooting.
• A strong understanding of cGMP, data integrity principles, laboratory quality systems and regulatory compliance; experience supporting regulatory inspections is desirable.
• Strong analytical and problem-solving skills, including familiarity with statistical tools and techniques used for troubleshooting, alongside an understanding of change control and variation management processes.
• Excellent written and verbal communication skills, with the ability to collaborate across teams, influence decisions, manage competing priorities and contribute to continuous improvement.

Due to the high volume of applications, we may not be able to respond to every applicant.