Scientist II (Molecular, PCR, Sequencing)

Thermo Fisher Scientific•Highland Heights, KY

1d•Onsite

About The Position

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.

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).
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 communication within the team and with stakeholders.
Displays exceptional time management and project management skills, ensuring efficient completion of tasks.
Proven problem-solving and troubleshooting abilities, enabling the identification and resolution 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 and productive team.
To demonstrate behaviors which align to the 4i Values of Thermo Fisher

Nice To Haves

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.

Responsibilities

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 analysis procedures with minimal supervision/guidance to quantitatively measure pharmaceutical and biopharmaceutical compounds in a variety of formulations and/or biological matrices for stability and analytical testing.
Completes all laboratory documentation in clear and accurate language and according to SOP and GLPs.
Independently troubleshoots equipment & instruments.
Mentors’ others in troubleshooting when applicable.
Reviews and compiles results from assignments and makes initial determination on acceptability per SOP acceptance criteria.
Performs work assignments accurately, and in a timely and safe manner.
Independently manages QC responsibilities.
Communicates' project status to project 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/Atypical investigation process.