Clinical Lab Technologist

Position Overview

The Clinical Lab Technologist position will be responsible for processing medically relevant biological samples through extraction and/or high throughput next-generation DNA sequencing assays. This role will work within a team of Laboratorians in a fast-paced, high production setting to process research and clinical diagnostic samples to provide test results to patients, oncologists and other medical practitioners and researchers. As such, high attention to detail and clinical mindedness are crucial to success in this role.

Adaptive’s clinical laboratories are CLIA/CAP/NYS/FDA certified, and as such this position needs to adhere to and uphold all applicable regulatory requirements.

This role is primarily based within our PCR team, with opportunities for cross-training in other lab areas as operational needs evolve.

Position level I, II, or III is determined by candidates’ education, experience, and competencies as defined below:

Scope/Impact

Level I

• Performs and provides general support for DNA extractions, PCR amplification, or high-throughput sequencing assays on DNA libraries in accordance with standard laboratory processes and procedures.
• Operates and maintains laboratory equipment such as liquid handling robotics and DNA sequencers.
• Completes tasks as assigned (e.g. routine clinical or research sample processing, validations, reagent QC runs, or special projects) accurately while following strict methodologies.
• Provides guidance to less-experienced staff.

Level II

All of the above with some guidance, as well as:

• Performs training and/or competency assessments for Clinical Laboratory Technician/Technologist team members on high complexity molecular methods.

Level III

All of the above with independence, as well as:

• Suggests changes to existing laboratory procedures and processes to improve efficiency and results.

Complexity

Level I

• Performs protocols under compliance with regulatory agencies, models appropriate clinical, regulatory and safety practices.
• Makes decisions that impact quality, timeliness, and effectiveness of the team.
• Resolves basic problems that may involve uncommon variations of issues.
• Identifies and uses up to date, accurate information for problem solving and analysis.
• Ensures compliance with lab regulatory agencies (GxP, FDA, ISO).
• Keeps accurate and detailed records for all workflows following Good Documentation Practices.

Level II

All of the above with some guidance, as well as:

• Suggests improvements to existing laboratory procedures and processes to improve the efficiency of the team.
• Works on assignments requiring considerable clinical judgement and initiative.
• Understands implications of their work performance and when to escalate issues upward.

Level III

All of the above with independence, as well as:

• Identifies and uses knowledge of how supporting teams function with own team.

Knowledge/Level of Expertise

Level I

• Demonstrates excellent clinical judgment and integrity by possessing specialized skills through job-related training and considerable on-the-job experience.
• Explains technical information within the team.
• Demonstrates understanding of underlying scientific principles of analytical methods and provides relevant information to Supervisor or Lead Technologist to assist with troubleshooting assay or instrument issues leading to appropriate corrective actions.
• Has strong communication skills to present problems or issues to Supervisor or Lead Technologist.
• Handles sensitive information confidentially.

Level II

All of the above with considerable knowledge/skills in a range of laboratory procedures.

Level III

All of the above with deep knowledge/skills in a range of laboratory procedures.

Interactions, Supervision and Discretion

Level I

• Exhibit clear and effective communication to facilitate effective handoff procedures.
• Follows standardized laboratory processes and procedures with some guidance on daily work.
• Uses clinical discretion to make recommendations for improving work procedures and processes to improve efficiency.

Level II

All of the above with minimal guidance, as well as:

• Provides guidance to more junior team members.

Level III

All of the above with independence, and frequently applies educated discretion in decision making.

Regulatory Responsibility

Level I, II, and III:

• Maintain continuing education credit requirements.
• Record nonconformances for all appropriate errors.
• Enter and track data in a laboratory information database (LIMS)
• Operate and maintain laboratory equipment such as liquid handling robotics and DNA sequencers.
• Regulatory responsibilities per Good Manufacturing Practices (GMP)
• Regulatory responsibilities per Good Clinical Practices (GCP)
• Regulatory responsibilities per Good Laboratory Practices (GLP)
• Regulatory responsibilities of “Testing Personnel” for high complexity testing as defined by 42CFR493.1495
• All other duties as assigned

Position Requirements (Education, Experience, Other)

Required

• Molecular biology skills (e.g. DNA Extraction, Purification, PCR, qPCR, next-generation DNA sequencing) and related technical knowledge.
• Experience working with human specimens (e.g. blood, tissues and/or cells) and biohazardous material.
• Strong communication and interpersonal skills, ability to collaborate across teams and disciplines.

As well as:

Level I

Must meet ONE of the following:

• Bachelor’s or higher in medical technology or laboratory science from an accredited institution, OR:
• Bachelor’s or higher in one of the chemical or biological sciences from an accredited institution + 6 months of high-complexity molecular experience and/or training in a clinical laboratory (holding a CLIA Certificate of Compliance/Accreditation)

Level II

Must meet ALL of the following:

• Bachelor’s or higher in medical technology or laboratory science, chemical science, or biological science from an accredited institution.
• Minimum of 1 year of experience and/or training in a clinical laboratory (holding a CLIA Certificate of Compliance/Accreditation) meeting the definition of “high-complexity”.
• Minimum of 3 years of pertinent molecular laboratory experience.
• Minimum of 2 years with a Master’s or higher.

Level III

Must meet ALL of the following:

• Bachelor’s or higher in medical technology or laboratory science, chemical science, or biological science from an accredited institution.

• Minimum of 3 years of experience and/or training in a clinical laboratory (holding a CLIA Certificate of Compliance/Accreditation) meeting the definition of “high-complexity”.
• Minimum of 2 years with a Master’s or higher.
• Minimum of 5 years of pertinent molecular laboratory experience.
• Minimum of 3 years with a Master’s or higher.

• Competent in laboratory automation and demonstrated laboratory best practices.

Preferred:

• ASCP(MB) certification
• Specialized knowledge and skills: Experience in a clinical, high-throughput environment is preferred.
• Working knowledge of laboratory terminology, equipment, and supplies.
• Competent in laboratory automation and demonstrated laboratory best practices.
• Experience working within an electronic Laboratory Information Management System
• Self-motivated and can work independently, with minimal supervision, while also working as part of a team environment in a dynamic organization. Strong interpersonal and communication skills, both written and spoken.
• Experience with Adaptive’s Sample Prep or PCR/Sequencing technologies or Methods.

Working Conditions

Job involves working in a laboratory handling human biological specimens. Employees work on assigned shifts which may include late evenings & weekends. Occasional flexibility and willingness to work more than assigned hours is expected.

PCR Laboratory

Tues–Sat: 2:30 PM – 11:00 PM

Individuals are required to sit or stand for much of the workday and perform data entry into computer systems.

Compensation:

Level I: $26.87 – $40.34 per hour

Level II: $30.24 – $45.34 per hour

Level III: $38.17 – $57.31 per hour

Other compensation elements include:

• Equity grant
• Bonus eligible