Research Scientist-E&L

At PPD part of Thermo Fisher Scientificyoulldiscover 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 healthiercleanerand safer.

We provide our teams with the resources needed to achieve individual career goals while taking science a stepbeyond throughresearchdevelopmentand 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 theexpertiseof scientists industrythought-leadersand therapeutic guides. As the world leader in serving science our laboratory professionals bring their commitment to accuracy and quality to deliver groundbreaking innovations.

Job Summary:
We are seeking an experienced Extractables & Leachables (E&L) Research Scientist with 8 years of industry experience to lead and execute E&L studies for pharmaceutical and medical device applications. The ideal candidate will have strong analytical expertise hands-on experience with chromatographic and spectrometric techniques and proven experience managing projects end-to-end within a GMP-regulated environment.

Key Responsibilities:

• Design execute and interpret Extractables & Leachables (E&L) studies in compliance with regulatory and GMP requirements.
• Develop optimize and validate analytical methods using HPLC GC GC-MS and LC-MS/MS.
• Perform complex E&L sample preparation including study design protocol development and validation activities.
• Conduct risk assessments and support toxicological evaluations in collaboration with cross-functional teams.
• Prepare technical reports study protocols and validation documentation for client and regulatory submissions.
• Manage projects end-to-end ensuring timelines quality standards and client expectations are met.
• Lead client interactions technical discussions and provide scientific guidance.
• Draft and manage Quality Notifications (QNs) and support investigations in GMP environments.
• Ensure compliance with internal SOPs regulatory guidelines and data integrity standards.

Required Qualifications:

• Masters or Ph.D. in Analytical Chemistry Pharmaceutical Sciences or related field.
• Minimum 8 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.
• Proven experience working in a GMP-regulated environment.
• Demonstrated experience in end-to-end project management and client-facing roles.
• Proficiency in technical documentation and Quality Notifications like Investigation and Non-Conformance.

Preferred Qualification:

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

This role requires strong analytical problem-solving skills attention to detail regulatory awareness and the ability to manage multiple projects in a fast-paced environment

Work Environment:
Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:
Able to communicate receive and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
Able to work upright and stationary and/or standing for typical working hours.
Able to lift and move objects up to 25 pounds.
Able to work in non-traditional work environments.
Able to use and learn standard office equipment and technology with proficiency.
May have exposure to potentially hazardous elements including infectious agents typically found in healthcare or laboratory environments.
Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.

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. Youll work in an environment where collaboration and development are part of the everyday experienceand where your contributions truly make a difference.

Apply today to help us deliver tomorrows breakthroughs.