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.
Position Overview
Provide technical functions and support for CLIA/CAP regulated high complexity clinical laboratory performing molecular testing using NGS; and assist with maintenance of laboratory compliance.
Responsibilities
- Provides review of assay QC data for trials and research studies, and first review of patient QC data (for subsequent review and approval by an individual qualified as a Clinical Laboratory Director)
- Assists with technical trouble-shooting and related quality improvement initiatives
- Develops, monitors and trends quality metrics and prepares monthly reports for review and approval by a Clinical Laboratory Director
- Authors and/or reviews laboratory requirement documents (e.g., Analytic Methods, SOPs) for approval by a Clinical Laboratory Director
- Reviews quality control and maintenance logs for completeness and accurate documentation
- Supports assessment of non-conformances and escalates to a Clinical Laboratory Director when there is a potential for impact to patient care
- Supports LIMS Development in collaboration with the software team (e.g., creates dashboards for tracking and prioritizing requests, generates user requirements, UAT cases and plans, completes test plans, and related documents for system features and enhancements)
- Assigns and monitors timely, accurate completion of proficiency testing for review and approval by the Clinical Laboratory Director
- Collaborates with Clinical Laboratory Directors to develop and continuously improve day-to-day operations and ensure cross-functional alignment with laboratory support groups
- Support and initiate activities, in conjunction with the Laboratory Technical Supervisor or Clinical Laboratory Directors to ensure laboratory compliance with applicable regulations
- Note that all responsibilities are to be defined to align with the definition of a Technical Supervisor under CLIA and NYS CLEP. All functions of at Technical Supervisor under CAP require oversight by a Clinical laboratory Director.
Requirements
- PhD in a chemical, physical, biological or clinical laboratory science from an accredited institution; and at least 1 year of laboratory training or experience in high complexity testing for clinical molecular pathology/genetics under the direct or indirect supervision of a board certified clinical laboratory director.
OR
- Master's degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and at least 2 years of laboratory training or experience in high complexity testing for clinical molecular pathology/genetics under the direct or indirect supervision of a board certified clinical laboratory director.
OR
- Bachelor's degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and at least 4 years of laboratory training or experience in high complexity testing for clinical molecular pathology/genetics under the direct or indirect supervision of a board certified clinical laboratory director.
PLUS
- Specialized knowledge, experience and skills: Molecular biology techniques (DNA extraction, PCR, Next-generation sequencing [NGS]), laboratory automation, Laboratory information management systems, reagent and instrument qualification, NGS data analysis, CAP/CLIA regulations.
Preferred experience, skills, and qualifications
- Experience reviewing Illumina sequencer analytics
- Strong communication and interpersonal skills
- Advanced critical thinking and problem solving skills
- Ability to work in a team environment
- Promotes a positive work environment while supporting management and business goals
- Experience within regulated GxP laboratory environment
- Ability to collaborate across teams and disciplines
- Creates a productive and professional culture
- Upholds clinical laboratory best practices; and complies with applicable regulations.
Working Conditions
Work in a clinical laboratory environment. May require entrance to laboratory and working with patient samples, and lab automation equipment. Prolonged periods of working at a computer. May include some time shadowing laboratory staff or working in the laboratory.
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.