About the Company
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.
About the Role
The Histotechnologist will be responsible for assisting Foresight in standing up the histology laboratory and for processing all specimens received under minimal supervision. This position will partner with the Laboratory Director, laboratory operations leadership, research and development, and medical affairs/clinical operations to select and implement methodologies and instrumentation utilized in processing tissue specimens. The Histotechnologist will also be cross trained to support processing of clinical and translational research samples from accessioning through sequencing. Under the guidance of the Senior Manager, Production Laboratory, you will work collaboratively within the production laboratory leveraging your technical knowledge, skills, and abilities to ensure efficient and quality results are provided to our clients and patients. The Histotechnologist will also inform and participate in process improvements through ownership and leadership. This position will report to the Senior Manager, Production Laboratory.
Responsibilities
Operations
- Perform routine and complex histology and laboratory testing on patient samples for clinical, biopharma, and academic partnerships.
- Provide technical guidance and training, as needed, to production personnel on histological processing of specimens to include methodology, instrumentation, staining, maintenance, waste disposal, etc.
- Support histology integration with Foresight’s LIMS as the technical SME for histology.
- Collaborate with cross functional teams to stand up Foresight’s histology laboratory and support research and development of new products requiring histology.
- Interpret data and results of all analyses according to set procedures and guidelines.
- Support day-to-day operations by assisting with data entry, receiving samples and consumables, reagent preparation, sample preparation, temperature recording, laboratory maintenance, and documentation.
- Identify and resolve problems that may adversely affect test performance or reporting of test results following the escalation path to production leadership as needed.
- Assist with research, translational research, and regulated products through the execution of partnership studies and internal/external validation 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.
- Propose assay and process improvements and conduct improvement activities under guidance.
- Demonstrate forward thinking and initiative in work planning and execution of work in order to achieve on-time report delivery.
- Participate in new or revised assay launches giving input on launch logistics as appropriate.
- Participate in work planning initiatives and scheduling.
- Author standard operating procedures (SOPs), process maps, decision trees, and/or training program materials to facilitate successful implementation of instrumentation into the clinical laboratory testing workflow.
- Perform and interpret special stains and immunohistochemistry procedures.
- Maintain accurate and detailed records of all tests performed, including any deviations from standard procedures.
- Collaborate with pathologists to review and interpret tissue samples.
- Implement and adhere to laboratory safety protocols to ensure a safe working environment.
Quality, Training & Equipment
- Maintain 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 laboratory quality metrics in collaboration with production and clinical operations leadership.
- Complete initial training and maintain competencies as current and up to date for all trained assays.
- Wear appropriate PPE as required and comply with safety rules and regulations.
- Follow standard operating procedures (SOP).
- Participate in IQ/OQ/PQ for equipment to ensure the ability to train team members on proper use and maintenance as appropriate.
- Escalate equipment issues that impact TAT or patient safety.
- Assist, perform, and review instrument correlation studies. Collaborate with operational leadership on equipment analysis for assay expansion or improvement.
- Perform instrument and procedural calibrations and maintenance.
- Advise and drive progress on troubleshooting equipment issues.
- Adhere to the laboratory's quality control policies including document control activities, change management, and corrective preventative action.
- Train internal production team to new instrumentation, products, processes, or assays to support successful implementation in the histology laboratory.
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 a role model for safety behavior standards and cultural tenets.
- Serve as a leader from the bench, demonstrating consistency in good lab practices.
Knowledge, Skills and Abilities
- 6+ years of relevant laboratory work experience.
- 2+ years of experience in ISO 13485/15189, GLP and or CAP/CLIA environments.
- Bachelor’s or Master's degree in chemical, physical, biological, or clinical laboratory science or medical technology from an accredited institution.
- Education received at a college or university located outside of the United States or United States Territories requires a credentials equivalency evaluation by an approved agency.
- Hold a current and active American Society of Clinical Pathology (ASCP) board certification.
- Hold current and valid Histotechnician (HT) or Histotechnologist (HTL) certification.
- Experience performing complex molecular biology workflows.
- Previous experience designing and performing validations and verifications, process development and process-directed documentation.
- Experience in complex problem-solving and risk management/mitigation (i.e. identify potential equipment or chemistry failures).
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, Pushing and Pulling, Crouching, Stooping & Kneeling, Lifting 40 lbs in 2-hour increments.
- Coordination: Manual Dexterity, Tactile Sensitivity, Repetitive movement.
- Communication & Vision: Verbal Communication, Written Communication, Color Vision, Depth Perception.
This role is offering an hourly rate between $29.75 - $34.50, 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 August 15, 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.
