Associate Research Scientist (PCR, Molecular) Full-time

Associate Research Scientist

This is a fully onsite role based at our Global Central Laboratory in Highland Heights, KY. We welcome applicants from all locations within the US. Please note that relocation assistance is not provided for this position, and any relocation costs will be the responsibility of the candidate. Must be legally authorized to work in the United States without sponsorship. Must be able to pass a comprehensive background check, which includes a drug screening.

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.

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

Role Summary

As an Associate Research Scientist you will independently design, develop, and execute validation studies supporting PCR, qPCR, RT-qPCR, and DNA sequencing assays performed on human samples in a CAP/CLIA-regulated laboratory environment.

This role is responsible for ensuring that laboratory instruments, analytical methods, and associated processes are validated, compliant, and consistently performing to required client and regulatory standards. The scientist interprets validation data, authors validation protocols and reports, leads troubleshooting activities, and drives corrective actions to ensure assay accuracy, precision, and reliability.

This position serves as a technical subject matter expert in molecular instrumentation and validation science while mentoring junior staff and supporting cross-functional quality initiatives.

What You'll Do:

• Trains on routine operation, maintenance, and theory of complex analytical instrumentation, SOPs, and regulatory procedures and guidelines.
• Independently performs and provides guidance on complex sample preparation and analytical procedures to quantitatively measure pharmaceutical and biopharmaceutical compounds across a variety of formulations and matrices for stability and analytical testing.
• Completes all laboratory documentation clearly, accurately, and compliantly, in accordance with SOPs and GLP requirements, with a strong emphasis on high-quality technical writing.
• Leads advanced troubleshooting for various equipment & instruments.
• Reviews and compiles results from assignments and makes determination on acceptability per SOP acceptance criteria. Reviews overall study results.
• Navigates the OOS/OOT/Atypical investigation process. Leads more complex investigations and Root Cause Analysis and leads CAPAs.
• Independently manages QC responsibilities. Communicates project status to project leader and helps to address gaps and solutions to overcoming roadblocks in project team workflow. May act as project leader.
• Coordinates laboratory activities of other team members in conjunction with lab management.
• Performs study design & protocol authoring. Leads data evaluation and study close-out.
• Independently completes QA facing tasks. Authors and leads more complex quality records (eg. quality records which may require more in-depth investigation to identify true root causes, quality records requiring cross-departmental input and/or collation of data etc.)
• Mentors other staff members in applicable areas.

Education and Experience Requirements:

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years).
• Preferred Fields of Study: Molecular Biology, Biochemistry, Biomedical Engineering, or related life sciences field

In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills, Abilities:

• Demonstrated experience with PCR, qPCR, RT-qPCR, and DNA sequencing in CAP/CLIA laboratory strongly preferred
• Ability to independently perform root cause analysis for quality records
• Proficiency on technical operating systems
• Proven problem solving and troubleshooting abilities
• Proven ability in technical writing skills
• Time management and project management skills • Good written and oral communication skills
• Ability to work in a collaborative work environment with a team
• Ability to train junior staff
• Ability to mentor others on technical operating systems
• Full understanding of laboratory requirements, SOPs, ICH guidelines, USP requirements and regulatory guidance

Work Environment:

• 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 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. You'll work in an environment where collaboration and development are part of the everyday experience—and where your contributions truly make a difference.

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values – Integrity, Intensity, Innovation and Involvement – working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Apply today to help us deliver tomorrow's breakthroughs!

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

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