Senior Research Scientist – Extractables/Leachables (LCMS & GCMS) Full-time

Senior Research Scientist

At 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 through our PPD clinical research portfolio, 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.

You would be joining a fast growing, successful team, operating at the cutting edge of the science of incorporating stakeholder preferences into health care decision making. We have developed an innovative, collaborative culture, aimed at developing and sharing good practice in preference research, both internally and externally. We are looking for someone who will thrive in this environment.

The Senior Research Scientist is responsible for the scientific scope, accuracy and regulatory alignment for method feasibility, development, and validation. Provides technical and regulatory consulting and oversight for internal groups and clients regarding method establishment programs. Oversees troubleshooting on multiple analytical instruments and multiple detection techniques, data calculation and interpretation, and records data in adherence with Thermo Fisher Scientific, Inc. SOPs and any additional requirements specific to the lab and / or client. Provides mentorship and technical guidance to scientific staff, acting as program lead to provide updates and reports for multiple clients, and collaborating with lab leaders to ensure client needs are met. The position also focuses on implementing strategies for project profitability and long-term quality improvements.

Key Responsibilities

• Train, mentor, and coach technical staff, translating extractables/leachables proposal scope to testing needs and guiding project closure and transition into routine leachable testing.
• Mentor analytical staff on technical writing, study design, and efficient testing, fostering independent test execution and troubleshooting.
• Leverage expertise in method establishment to support project execution on multiple Lcms and GCMS technologies internally and with clients.
• Drive business decisions and process improvements as a technical expert and execute new strategies for technical advancement.
• Develop staff identified by lab leaders (TOMs) as candidates for method establishment project work.
• Identify roadblocks and implement strategies during method establishment that positively impact downstream routine work (method life cycle management).
• Function as the technical point of contact for overall client relationship for method establishment work, providing guidance or recommendations to clients based on the phase of work and long-term testing needs and strategies.
• Communicate project plans, updates, and technical issues to clients, ensuring clear and respectful communication.
• Drive risk assessments, advise clients on regulatory guidance, and recommend risk mitigation strategies.
• Manage overall client portfolio for method establishment testing (timelines, expectations, quality).
• Drive client growth by expanding relationships & identifying future opportunities.
• Oversee and review protocols, data, final reports, quality records associated with projects to ensure integrity and compliance with SOPs and industry requirements.
• Participate in problem-solving sessions, escalate issues when necessary, and incorporate appropriate resources or SMEs to drive effective solutioning.
• Aid in preparation for and participate in client meetings, audits, or site visits, supporting efforts to enhance customer satisfaction and expand client relationships.

Education and Experience

• BS degree and previous experience that provides the knowledge, skills, and abilities to perform the job (10+ years) or equivalent combination of education, training, & experience.
• OR Masters degree and previous experience that provides the knowledge, skills, and abilities to perform the job (9+ years)
• OR PhD and (comparable to 6+ years)
• Proven experience in LCMS and GCMS.
• Extensive experience developing and validating methods for extractables and leachables or similar.
• Demonstrated ability to manage multiple projects simultaneously.
• Outstanding problem-solving skills and meticulous attention to detail.
• Ability to strictly adhere to regulatory guidelines and quality standards.
• Excellent communication and collaboration skills.

Knowledge, Skills, Abilities

• Expertise in LCMS and GCMS analytical testing and applicable technology/instrumentation, preferably high resolution chromatography
• Excellent organizational skills with the ability to adapt and adjust to changing priorities while maintaining focus, composure and productivity
• Versed in data analysis to identify trends or outliers
• Ability to manage multiple assignments with challenging/conflicting deadlines
• Strong statistical analysis skills
• Proficient in Microsoft suite applications (eg: Word, Excel, PowerBI, PowerPoint, Teams, Sharepoint)
• Strong attention to detail and problem-solving skills
• Effective written and verbal communication skills
• Demonstrated experience in identification and resolution of conflicts in a professional environment
• Ability to maintain a high degree of confidentiality with client information and data
• Ability to attain, maintain and apply a working knowledge of applicable procedural documents
• Demonstrated positive attitude, enthusiasm toward work, and the ability to work well with others
• Demonstrated ability to receive and apply constructive feedback
• Ability to train, coach and mentor junior staff

Work Environment

We value 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 & ideas with diverse groups of people in a comprehensible and reasonable manner.
• Able to work upright and stationary for typical working hours.
• Ability to use and learn standard office equipment and technology with proficiency.
• Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
• May require travel.

Benefits

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!