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Accessioning Lead

2 months ago

Boulder, United States Foresight Diagnostics Full time

Job Title: Accessioning Lead

Company Summary

Foresight Diagnostics is an early-stage, venture-backed molecular diagnostics company that is developing non-invasive cancer detection technologies to improve the lives of patients worldwide. Our portfolio of cell-free DNA based liquid biopsy tests are rooted in novel and proprietary methods developed at Stanford University. Our approach enables the earlier detection of smaller tumors, leading to more personalized and effective cancer treatment strategies for patients. We have deep expertise in molecular biology, bioinformatics, and Next Generation Sequencing (NGS), and maintain a dynamic, fast-paced work environment with significant opportunities for high-impact contribution and rapid professional growth. Foresight Diagnostics is headquartered in Boulder, Colorado.

Position Summary

The Accessioning Lead will be responsible for performing accessioning activities in support of research, regulated products, and clinical testing. Under the guidance of the Site Lead you will work collaboratively within the cross functional laboratory teams leveraging your technical knowledge, skill and abilities to ensure efficient processing of samples upon receipt and quality results are provided to our partners and patients through proper sample handling, documentation, and storage. The Accessioning Lead will collaborate with the Alliance Management and Clinical Operations departments to manage external communication in support of partner studies and clinical testing. This position will report to the Site Lead.

Responsibilities

Support day to day operations by receiving samples and completing the accessioning intake process ensuring sample integrity

Develop and implement processes and procedures to support continuous improvement of the accessioning function

Collaborate cross functionally on LIMS development, implementation and integration as the accessioning SME

Route samples to storage or directly to a downstream lab team member for immediate processing

Identify and implement rejection criteria and documentation for samples following the escalation path to leadership as needed

Maintain all required documentation to ensure chain of custody

Collaborate with Alliance Management and Clinical Operations to support and enable external communication with partners in support of accessioning activities before, during and after study execution, to include participation in study kickoff meetings with external partners to educate on sample requirements and answer questions to enable successful outcomes for each study, reconciliation of samples received and outstanding, and return or disposal of samples per contractual obligations

Safely handle, store, requeue, troubleshoot or discard specimens as defined by the SOP

Appropriate handling of biohazard waste, including labeling and disposal

Ensure regulatory compliance by following local, business, regulatory body and corporate safety policies

Propose, and participate in process improvements for the accessioning process under guidance from the Site Lead

Source samples to support research and regulated product development and internal studies

Assess, scope and triage new projects/products in coordination with the Site Lead

Develop and maintain the sample retention program and documentation to support internal research and regulated product development and studies

Participate as a contributing member of the production laboratory by assisting in routine activities, to include but not limited to general upkeep and stocking, SOP author and review, and continuous improvement

Attend and participate in cross functional meetings

This role will have direct supervisory responsibilities

Quality, Training & Equipment

Maintaining documentation in compliance with Good Laboratory Practices and Quality Systems

Assist with quality control and quality assurance activities. Responsible for reviewing and analyzing the health of accessioning quality metrics in collaboration with the Site Lead

Wear appropriate PPE as required and comply with safety rules and regulations

Follow standard operating procedures (SOP)

Maintain laboratory equipment and instrumentation in accordance with the SOP.

Adhere to the laboratory's quality control policies including document control activities, change management, corrective preventative action

Act as a trainer for accessioning team members

Team

Cultivate, build and maintain positive and collaborative relationships within teams and cross-functionally

Operate as a thought leader and hold cross-functional teams accountable to regulatory, quality, scientific and performance standards to ensure the highest quality for sample integrity

Seen as role model for safety behavior standards and cultural tenets

Serves as a leader from the bench, demonstrating consistency in good lab practices

Knowledge, Skills and Abilities

Bachelor’s degree in chemical, physical, biological, or clinical laboratory science or medical technology from an accredited institution

3+ years experience handling human biological materials in an accessioning department in a CLIA laboratory, CRO, or other clinical diagnostics setting

Previous leadership experience preferred

Experience with hiring/staffing preferred

Experience with LIMS

Excellent data entry skills

Working knowledge of how to safely operate in a BSL-2 environment is required

Advanced attention to detail and organizational skills

Excellent verbal and written communication skills

Working Conditions and Physical Effort

Staff in this role must be able to perform the essential functions of the job with or without a reasonable accommodation. Certain physical activities may be required in order to perform the essential functions of this job. Examples of these requirements include but are not limited to the following:

Strength & Endurance

Standing, Walking Sitting: 2 hour increments

Pushing and Pulling

Crouching, Stooping & Kneeling

Lifting: 40 lbsCoordination

Manual Dexterity

Tactile Sensitivity

Repetitive movementCommunication & Vision

Verbal Communication

Written Communication

Color Vision

Depth Perception

This role is hourly, non-exempt, with a hiring range between $35.35/hour - $45.70/hour, is eligible for a 10% shift differential for Saturday hours, and is eligible for equity offerings.

Foresight offers benefits including paid vacation, sick time, and parental leave (if applicable), alongside medical, dental, vision, life, disability coverage, flexible spending accounts, and a 401k with company match. 

The application deadline for this position is September 30, 2024

You will be working on interesting problems with extremely high impact. We promote the professional development of our employees and will encourage upward mobility within the company for high performing employees. Foresight Diagnostics is an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.