Analytical Chemist – GMP Testing & Lab Innovation

PSC Biotech Corporation; Tipperary; On-site; EUR 40,000 - 60,000; Full time

Job summary

PSC Biotech Ireland in Ballydine is hiring a quality analytical chemist to perform and document testing of raw materials, intermediates, and drug substances using approved methods. You will support investigations, technology transfers, method development, stability programs, and train lab personnel while ensuring cGMP compliance and data integrity.

The role involves reviewing data and batch documentation prior to release and mentoring junior analysts in a fast-paced biotech environment.

Qualifications

• GMP compliance and quality systems knowledge.
• Proficiency in analytical techniques, instrumentation, maintenance and troubleshooting.
• Strong understanding of data integrity and ALCOA principles.

Responsibilities

• Perform testing of raw materials, intermediates, drug substances, and drug products in line with approved methods and specifications.
• Provide analytical support for quality investigations, technology transfers, method development, stability programs and training of laboratory personnel.
• Accurately document testing activities and maintain laboratory records in electronic systems.
• Support and lead analytical investigations, including OOS and quality notification activities.
• Review and verify analytical data and batch documentation prior to product release.
• Provide analytical support for process changes, technology transfers, product demonstrations, and non-routine testing.
• Identify, troubleshoot, and resolve analytical and laboratory-related issues.
• Lead or contribute to continuous improvement, change management and site initiatives.
• Train, mentor, and support the development of laboratory analysts and apprentices.

Skills

GMP awareness

Analytical techniques

Data integrity/ALCOA

Education

BSc in Chemistry

Job description

PSC Biotech Ireland in Ballydine is hiring a quality analytical chemist to perform and document testing of raw materials, intermediates, and drug substances using approved methods. You will support investigations, technology transfers, method development, stability programs, and train lab personnel while ensuring cGMP compliance and data integrity.

The role involves reviewing data and batch documentation prior to release and mentoring junior analysts in a fast-paced biotech environment.