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Sr. Scientist - Clinical Genomics
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Work Schedule
Standard (Mon-Fri)Environmental Conditions
Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs 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.
Within our Analytical Services team, we have a functional service provider solution, which is a unique partnership that allows our customers to leverage the experience of our staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits.
Key responsibilities:
The clinical genomics research scientist is responsible for helping develop genomics biomarker strategy and implement on programs. This includes but is not limited to responsibilities for genomics and gene expression profiling (GEP) biomarker assay technology/ platform selection, evaluation of in-house or vendor choice per assay use requirements, development, optimization, qualification/validation and execution of biomarker analysis for translational medicine and clinical programs. Successful candidates must have a strong technical background in genomics and transcriptomics and its application in clinical programs, additional specific requirements listed below:
- Developing genomics and transcriptomics strategies with biomarker leads, data analysis, and trial operations teams.
- Focusing 100% on lab work, requiring onsite attendance.
- Designing and developing genomics/transcriptomics assays, including broad genomic/GEP profiling, pharmacodynamic, target engagement, predictive, and prognostic assays.
- Developing, optimizing, qualifying/validating, and executing biomarker assays, both in-house and with external vendors.
- Overseeing assay/workflow development and analyzing qualification/validation data.
- Providing subject matter expertise and oversight for outsourced studies.
- Drafting experimental plans, qualification protocols, reports, SOPs, technology transfer documents, and study summaries.
- Participating in internal/external collaborations and clinical study teams.
- Assessing and onboarding relevant technologies through due diligence and pilot projects.
- Working closely with data analysis, sample management, and clinical operation teams.
- Providing mentorship and leadership within the lab team.
- Developing efficient genomics processes and best practices.
Education and Experience:
- Bachelor's degree in lab sciences such as Chemistry, Biochemistry, Material Science, Immunology, Biology, Molecular Biology or similar
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 4+ years’)
- OR Masters degree and previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years’)
- OR PhD
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 and Abilities:
- Prior experience working in a CLIA-licensed lab is a plus.
- Must be capable of working and operating in a laboratory environment for the entirety of the work schedule.
- Significant experience with NGS or GEP applications is required.
- Demonstrated experience in assay development for genomics assets, preferably in a pharma, biotech, diagnostic, or clinical lab setting.
- In-depth, hands-on experience with genomics platforms (NGS, qPCR, variant analysis) for assay development, qualification/validation, troubleshooting, and reviewing run QC data.
- Experience with technologies for ctDNA and GEP analysis is critical.
- Understanding of fit-for-purpose genomics assay validation principles for clinical assays.
- Knowledge of clinical sample analysis regulatory and quality frameworks (e.g., GCP, CLIA, CAP, NYDOH) is a plus.
- Strong organizational and collaborative skills are essential.
Working Environment:
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.
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!
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Nos aseguraremos de que las personas con discapacidades reciban adaptaciones razonables para participar en el proceso de solicitud de empleo o entrevista de trabajo, para que puedan ejercer las funciones de trabajo esenciales y recibir otros beneficios y privilegios del empleo. Comuníquese con nosotros para solicitar una adaptación.