Work Schedule
Standard (Mon-Fri)Environmental Conditions
Laboratory Setting, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Strong Odors (chemical, lubricants, biological products etc.)Job Description
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.
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.
Role Summary
As a Scientist II, you will develop expertise in the operation, maintenance, and scientific principles of molecular and genomics-based laboratory instrumentation, while ensuring adherence to standard operating procedures (SOPs) and regulatory requirements (e.g., CAP/CLIA). You will apply your knowledge of laboratory workflows to independently perform complex sample preparation and analysis on clinical trial specimens, including nucleic acid extraction, PCR/qPCR, sequencing, and other genomics assays to generate high-quality, reliable data.
You will be responsible for reviewing, analyzing, and validating results against established acceptance criteria, study protocols, and quality standards, ensuring accuracy and integrity of data within laboratory systems such as Preclarus.
In this role, you will collaborate across teams to support the end-to-end central lab workflow, from sample receipt and accessioning through testing and reporting, while contributing to continuous improvement efforts that enhance data quality, operational efficiency, and overall study delivery.
What You'll Do:
Trains on routine operation, maintenance, and theory of analytical
instrumentation, SOPs, and regulatory procedures and guidelines.
Performs a variety of routine to complex sample preparation and analysisprocedures with minimal supervision/guidance to quantitatively measurepharmaceutical and biopharmaceutical compounds in a variety of formulationsand/or biological matrices for stability and analytical testing.
Completes all laboratory documentation in clear and accurate language andaccording to SOP and GLPs.
Independently troubleshoots equipment & instruments. Mentors’ others introubleshooting when applicable.
Reviews and compiles results from assignments and makes initial determinationon acceptability per SOP acceptance criteria.
Performs work assignments accurately, and in a timely and safe manner.
Independently manages QC responsibilities. Communicates' project status toproject leader and helps to
Identify gaps and anticipates roadblocks in project team workflow.
Completes QA facing tasks with minimal supervisor/QA input.
Authors low complexity quality records and participates in the OOS/OOT/Atypicalinvestigation process.
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 2+ 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:
Hands-on experience with molecular techniques including PCR, qPCR, RT-qPCR, DNA sequencing, and other genomics-based assays strongly preferred
Prior experience working in a CAP/CLIA-regulated laboratory environment preferred
Knowledge of routine operation, maintenance, and theory of analytical instrumentation,SOPs, and regulatory guidelines.
Knowledge of applicable regulatory authority, compendia and ICH guidelines
Demonstrates excellent manual dexterity skills, allowing for precise and accurate work.
Exhibits strong written and oral communication skills, facilitating effective communicationwithin the team and with stakeholders.
Displays exceptional time management and project management skills, ensuring efficientcompletion of tasks.
Proven problem-solving and troubleshooting abilities, enabling the identification andresolution of issues.
Capable of cross-training on sample preparation techniques with another laboratory group,enhancing versatility and collaboration.
Thrives in a collaborative work environment, actively contributing to a cohesive andproductive team.
To demonstrate behaviors which align to the 4i Values of Thermo Fisher
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 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!http://jobs.thermofisher.com
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.
Accessibility/DisabilityAccess
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