Study Lead, Pharma Lab (GMP) & Data Delivery

ThermoFisher Scientific; Athlone; On-site; EUR 70,000 - 110,000; Full time

Job summary

Thermo Fisher Scientific is seeking an experienced Study Lead in Athlone, Ireland, to manage multiple routine projects including release, stability, and QC. The role requires strong HPLC expertise, GMP experience, and the ability to communicate updates to clients and internal stakeholders.

You will design studies, develop and validate analytical methods, prepare reports and ensure data integrity and regulatory compliance while mentoring junior staff and coordinating with cross‑functional teams.

Qualifications

• Bachelor’s degree in Analytical Chemistry or Pharmaceutical Sciences or related field.
• Minimum 5+ years of relevant industry experience.
• Strong hands‑on experience with HPLC and other analytical testing.
• Expertise in study design, analytical method development, validations and transfers.
• Experience in a GMP-regulated environment.
• Ability to manage multiple assignments with challenging deadlines.

Responsibilities

• Collaborate with stakeholders to translate requirements into study design plans and timelines.
• Direct routine study activities and ensure timely, quality deliverables.
• Communicate plans, status updates, and findings to clients and internal teams.
• Provide guidance and training to laboratory staff and troubleshoot issues.
• Prepare and review study protocols, reports, and quality records.
• Monitor data integrity and regulatory compliance across studies.
• Support risk assessments and continuous improvement initiatives.
• Escalate non‑routine issues to senior staff and clients as needed.

Skills

HPLC

Analytical testing

Study design & method development

Data review & SOP compliance

Mentoring junior staff

Education

Bachelor's degree in Analytical Chemistry or Pharmaceutical Sciences

5+ years relevant industry experience

Tools

Data collection software

Job description

Thermo Fisher Scientific is seeking an experienced Study Lead in Athlone, Ireland, to manage multiple routine projects including release, stability, and QC. The role requires strong HPLC expertise, GMP experience, and the ability to communicate updates to clients and internal stakeholders.

You will design studies, develop and validate analytical methods, prepare reports and ensure data integrity and regulatory compliance while mentoring junior staff and coordinating with cross‑functional teams.