We are powering the age of immune medicine- you can too. At Adaptive, our goal is to meaningfully improve people's lives by learning from the wisdom of the adaptive immune system.
As an Adapter, you will be surrounded by driven colleagues who think boldly to pursue ground-breaking innovation. You will experience meaningful challenge in your work and be fueled by motivating energy knowing you make a difference in people's lives.
You belong here- come discover your story at Adaptive.
The Research Associate II, QC Development, will play a critical role in the development, validation, and transfer of new analytical test methods for both new and existing IVD and LDT products. This position will participate in cross-functional teams contributing to the development of IVD and LDT products under design control, in accordance with ISO 13485 and Good Manufacturing and Laboratory Practices (GMP/GLP) and will take part in specification setting, stability studies, reagent and QC method development, optimization, troubleshooting, and verification and validation activities related to product development and quality control.
Participate in efforts to support the development of IVD products under design control in conformance with ISO-13485 (2016) or FDA 21 CFR Part 820 requirements.
Participate in the development of new PCR-based assays for reagent qualification for incoming material, in-process material, and final release product using next generation sequencing in collaboration with manufacturing, computational biology, and production service laboratory.
Perform experiments for QC method validation and stability studies, execute laboratory protocols, review, and analyze data, interpret results, and draft reports. Record all experimental details in an electronic notebook system.
Review required documentation including reagent quality control testing procedures, incoming material specifications, protocols and reports for verification and validation studies, and studies required to transfer reagent products into production (eg. stability, specification-setting, and related studies).
Support compliance with applicable regulations and quality-related best practices for development, validation, use, and documentation of assay development, analytical and functional quality control test methods for reagent lot qualification, stability studies, and related activities.
Additional duties as assigned.
BS/BA or equivalent in molecular biology, biochemistry, chemistry, engineering or related field with 2 years of laboratory experience, or MS with 1 year of lab experience.
Experience in analytical method development, QC for nucleic acid isolation, purification and quantitation, PCR, qPCR, and next generation sequencing assays.
Experience with executing molecular assays using liquid handling platforms is desirable.
Experience with assay verification, validation and method transfer is desirable.
Proven critical thinking skills and ability to perform proper trouble shoot.
Windows OS, Mac OS, and MS Office literacy required, familiarity with a programming language a plus.
Excellent communication and collaboration skills are required.
Ability to maintain open, constructive communication and collaboration with colleagues and management.
Ability to prioritize and adapt to changing priorities while maintaining a high standard of quality.
Ability to work in a fast-paced, multidisciplinary, and dynamic environment while managing multiple activities simultaneously.
Experience with IVD product development activities for PMA submission.
Experience with LIMS is recommended but not required.
Job requires laboratory work in a BSL-II lab handling biological material including: blood, bone marrow, and tissue. Work occasionally requires flexible and/or extended hours. Staff may have to periodically spend extended periods of time standing/sitting within the lab while executing repetitive work.
Adaptive Biotechnologies is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Equal Opportunity Employer/Veterans/Disabled
NOTE TO EMPLOYMENT AGENCIES: Adaptive Biotechnologies values our relationships with our Recruitment Partners and will only accept resumes from those partners whom have been contracted by a member of our Human Resources team to collaborate with us. Adaptive Biotechnologies is not responsible for any fees related to resumes that are unsolicited or are received by any employee of Adaptive Biotechnologies who is not a member of the Human Resources team.