Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
Role: Scientist Biomarkers
This is a fully onsite role based at our customers site in Collegeville PA 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 withoutsponsorship.
Must be able to pass a comprehensive background check whichincludes a drug screening.
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 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 whileallowing you the employee to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company all while maintaining full-time benefits.
Summarized Purpose:
Testing of clinical biological samples for various biomarkers using immunoassay platforms (MSD Quanterix etc.) in a GCP compliant environment.
Essential Functions:
Perform routine testing of clinical biological samples (primarily serum) to support biomarker analysis using validated immunoassay methods in a Good Clinical Practice (GCP) compliant laboratory.
Execute assays on immunoassay platforms such as Meso Scale Discovery (MSD) and similar technologies (e.g. Quanterix) following established standard operating procedures (SOPs).
Prepare handle and process clinical samples in accordance with laboratory safety procedures and biohazard handling guidelines.
Conduct testing using validated methods with minimal method development responsibilities ensuring data quality accuracy and adherence to study timelines.
Document all laboratory activities clearly and contemporaneously in compliance with GCP internal quality standards and regulatory requirements.
Review assay results for accuracy and completeness; identify routine technical issues and escalate concerns appropriately.
Support clinical study workflows including sample receipt tracking preparation analysis and data reporting.
Assist with assay validation activities and laboratory investigations as assigned.
Maintain laboratory equipment reagents and consumables to ensure operational readiness and inspection readiness.
Collaborate with team members to meet project milestones and contribute to a compliant organized laboratory environment.
Education and Experience:
Bachelors degree in related area with 2 years of experience in a regulated bioanalytical laboratory.
In somecasesan 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:
Immunoassay experience and experience with Watson LIMS preferred.
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. Youll work in an environment where collaboration and development are part of the everyday experience and where your contributions truly make a difference.
Apply today to help us deliver tomorrows breakthrough.
Required Experience:
IC
Work ScheduleStandard (Mon-Fri)Environmental ConditionsOfficeJob DescriptionRole: Scientist BiomarkersThis is a fully onsite role based at our customers site in Collegeville PA We welcome applicants from all locations within the US. Please note that relocation assistance is not provided for this pos...
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
Role: Scientist Biomarkers
This is a fully onsite role based at our customers site in Collegeville PA 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 withoutsponsorship.
Must be able to pass a comprehensive background check whichincludes a drug screening.
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 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 whileallowing you the employee to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company all while maintaining full-time benefits.
Summarized Purpose:
Testing of clinical biological samples for various biomarkers using immunoassay platforms (MSD Quanterix etc.) in a GCP compliant environment.
Essential Functions:
Perform routine testing of clinical biological samples (primarily serum) to support biomarker analysis using validated immunoassay methods in a Good Clinical Practice (GCP) compliant laboratory.
Execute assays on immunoassay platforms such as Meso Scale Discovery (MSD) and similar technologies (e.g. Quanterix) following established standard operating procedures (SOPs).
Prepare handle and process clinical samples in accordance with laboratory safety procedures and biohazard handling guidelines.
Conduct testing using validated methods with minimal method development responsibilities ensuring data quality accuracy and adherence to study timelines.
Document all laboratory activities clearly and contemporaneously in compliance with GCP internal quality standards and regulatory requirements.
Review assay results for accuracy and completeness; identify routine technical issues and escalate concerns appropriately.
Support clinical study workflows including sample receipt tracking preparation analysis and data reporting.
Assist with assay validation activities and laboratory investigations as assigned.
Maintain laboratory equipment reagents and consumables to ensure operational readiness and inspection readiness.
Collaborate with team members to meet project milestones and contribute to a compliant organized laboratory environment.
Education and Experience:
Bachelors degree in related area with 2 years of experience in a regulated bioanalytical laboratory.
In somecasesan 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:
Immunoassay experience and experience with Watson LIMS preferred.
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. Youll work in an environment where collaboration and development are part of the everyday experience and where your contributions truly make a difference.
Apply today to help us deliver tomorrows breakthrough.
Required Experience:
IC
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