Sr Scientist - Clinical Genomics
Sr Scientist - Clinical Genomics
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1 Vacancy
Job Description
Work Schedule
Standard (MonFri)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 youll 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 lifechanging 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 fulltime 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 inhouse or vendor choice per assay use requirements development optimization qualification/validation and 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 inhouse 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:
- Bachelors 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 CLIAlicensed 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.
- Indepth handson 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 fitforpurpose 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 nontraditional 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 forwardthinking organization and outstanding career and development prospects. We offer an exciting company culture that stands for integrity intensity involvement and innovation!
Required Experience:
Senior IC
Employment Type
Full-Time
