Thermo Fisher's clinical research business is a leading global contract research organization and world leader in serving science. We are passionate, deliberate, and driven by our mission - to enable our customers to make the world healthier, safer, and cleaner.
Location/Division Specific Information:
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.
A Day in the Life:
As a Research Scientist you will have knowledge and background in pharmacogenetics, genomics and molecular cell biology. Ideally, you would have prior experience with the development, validation of genotyping and gene expression assays used for clinical trial sample analysis. Work on complex projects in concert with discovery, biomarker, and clinical scientists to impact our client's organization at multiple levels of drug development.
Essential Functions:
MUST HAVE: Next-Generation Sequencing (NGS) and Microbiology background
Work independently or in collaboration with internal and/or external partners in analytical lifecycle activities including method development, validation, and method transfer
Be a key Subject Matter Expert (SME) and represent ASAT to participate in troubleshooting and OOS investigation occurred during release and/or stability testing
Provide SME assessment for deviation, CAPA and change control
Participate in internal and external meeting
Author and/or review technical documents, including method SOP, study protocol and technical report
Keys to Success:
Education
Bachelor's degree in microbiology or molecular biology, genetics or equivalent and relevant formal academic / vocational qualification
Experience
Pevious experience that provides the knowledge, skills, and abilities to perform the job: comparable to 8+ years
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:
Experience with NGS is a highly preferred skill (e.g., Illumina, nanopore, next seq, nova seq, hi seq, SMRT sequencing, Sequel, HiFi sequencing etc.).
Previous hand on experience with handling human DNA and RNA, working with and troubleshooting automated workflows utilizing systems such as Tecan and Perkin-Elmer, Applied Biosystems, Affymetrix and Illumina (7900, Viia7, Quant-Studio, MiSeq, NextSeq) software is strongly preferred.
Experience of using JMP or similar statistical tools is plus
Hands-on experience and In-depth knowledge of in-vitro cell-based potency assays
Experience in Gene and Cell therapy is desirable
Knowledge of relevant ICH and regulatory guidelines and good understanding of GMP concept.
Experience with analytical support for late-stage or commercial biological products and cGMP manufacturing
Ability to prioritize objectives from multiple projects and adhere to scheduled timelines while maintaining flexibility and efficiency
Working 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, including infectious agents, typically found in healthcare or laboratory environments.
Able to perform successfully while prioritizing and handling multiple projects or activities.
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! 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/Disability Access
Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.
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