Study Lead - Extractable & Leachables

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Laboratory Setting, Office

Job Description

Study Lead – E&L/Mass Spec

We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.

At PPD, part of Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer.  

We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research, our work spans laboratory, digital and decentralized clinical trial services.  

Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.  

 

Location/Division Specific Information  

Our PPD® Laboratory Services team has a direct impact on improving patient health through the expertise of scientists, industry thought-leaders and therapeutic guides. As the world leader in serving science, our laboratory professionals bring their commitment to accuracy and quality to deliver groundbreaking innovations.  

This role is based in the Extractable & Leachable team at our GMP Analytical testing laboratory in Athlone, Ireland.

 

Job Summary:
We are seeking an experienced Study Lead who will be responsible for managing multiple routine projects (release, stability, and quality control), interacting with clients and internal stakeholders to communicate updates, providing deliverables, reviewing and evaluating data, writing scientific reports and protocols, and managing

quality records. The Study Lead directs and oversees testing and troubleshooting on established methods using multiple analytical instruments and detection techniques, evaluates/trends and interprets data, and records data in adherence with Thermo Fisher Scientific, Inc. SOPs and any additional lab or client specific requirements.

The Study Lead is accountable for timely and accurate delivery of routine study outputs, ensuring data integrity, adherence to SOPs and regulatory requirements, and escalating issues to stakeholders and senior technical staff in accordance with established decision frameworks.

 

Key Responsibilities:

• Collaborate with internal stakeholders to translate project requirements into study design plans and manage project timelines and deliverables.
• Reinforces best practices through example and delivery of routine study activities.
• Communicate project plans, status updates, deliverables, and routine technical findings to internal stakeholders and clients, escalating risks, concerns, or non-routine issues as appropriate.
• Manages multiple routine projects, interacts with clients and internal stakeholders to communicate updates, provides deliverables, reviews and evaluates data, writes reports and protocols, and oversees quality records.
• Provide guidance, resources, mentoring, and/or training to laboratory staff, fostering independent routine test execution and troubleshooting.
• Prepare and/or review routine study protocols, project status reports, final study reports, and other project-related technical documents inclusive of quality records.
• Collate, organize, and evaluate/trend data to ensure accuracy, integrity, and compliance with protocols, methods, and SOPs.
• Monitor daily project-related operations to ensure adherence to SOPs, company policies, and regulatory standards, reporting non-compliance issues to management.
• Assist in risk assessments, recommend risk mitigation strategies, and advise clients on study design.
• Support continuous improvement initiatives, identify technical obstacles, and implement process improvement strategies.
• Participate in project problem-solving sessions, escalate issues when necessary, and incorporate appropriate resources or SMEs to drive effective solutioning.
• Executes/oversees studies within established methods, protocols, and decision frameworks, escalating non-routine, complex, or ambiguous issues to senior technical staff.
• Accountable for timely and accurate delivery of routine project outputs, ensuring data integrity and compliance with SOPs, regulatory requirements, and client expectations.
• Applies standard troubleshooting approaches to resolve routine technical issues, leveraging existing knowledge, historical data, and subject matter expert (SME) guidance as needed.
• Identifies and communicates risks to project timelines, data quality, or deliverables, and escalates appropriately.
• Support audit readiness by ensuring study documentation, data, and records are complete, accurate, and inspection-ready; participate in client audits or site visits and address audit findings under guidance from senior staff

 

Required Qualifications:

• Bachelors Degree in Analytical Chemistry, Pharmaceutical Sciences, or related field.
• Minimum 5+ years of relevant industry experience in Extractables & Leachables studies.
• Strong hands-on experience with HPLC, GC, GC-MS, and LC-MS
• Expertise in E&L sample preparation techniques, study design, and analytical method validations. handling various types of LCMS instrumentation for example LCMS-QQQ/Sciex 6500 or similar, Orbitrap or other high resolution LCMS instrumentation and with complex data evaluation and processing 
• Experience with Extractable and Leachables

 

• Proven experience working in a GMP-regulated environment.
• Ability to manage multiple assignments with challenging/conflicting deadlines
• Familiarity of data collection software leveraged for analytical testing
• Ability to attain, maintain and apply a working knowledge of applicable procedural documents
• Ability to train, coach and mentor junior staff

 

Preferred Qualification:

• Experience with ICP-MS (Inductively Coupled Plasma Mass Spectrometry) is a strong plus.

Why Join Us?
When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment where collaboration and development are part of the everyday experience—and where your contributions truly make a difference.

Apply today to help us deliver tomorrow’s breakthroughs.

 

We welcome and encourage applicants from outside of Ireland.  We can provide support with immigration and visa needs for successful applicants and dependents, tax consultations and other basic destination services.  All other relocation costs are at the expense of the applicant.