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Lead Pre-Analytical Supervisor

2 months ago

Brisbane, California, United States CareDx, Inc. Full time
Job Overview

CareDx, Inc. stands at the forefront of precision medicine, dedicated to the innovation, development, and commercialization of unique healthcare solutions tailored for transplant patients and their families. Our offerings encompass products, testing services, and digital health solutions that guide patients through their pre- and post-transplant journeys, making us the premier provider of genomics-based insights for transplant recipients.

The Pre-Analytical Supervisor will be responsible for overseeing the intake and accessioning processes of specimens received at the CareDx clinical laboratory. This role involves managing the performance of laboratory personnel in relation to specimen handling and ensuring adherence to established standard operating procedures. Additionally, the supervisor will actively participate in specimen accessioning, particularly during peak periods and staff shortages. This position serves as a crucial link between the specimen handling department and customer service, the Reflab clinical laboratory, and the Clinical Operations team, facilitating the coordination of specimen receipt and tracking for various studies.

Key Responsibilities:

  • Oversee the daily operations of the Laboratory Support function.
  • Ensure adequate staffing and scheduling for the accessioning and laboratory support functions; assist with accessioning during high-demand periods and staff absences.
  • Guarantee that all work is performed in alignment with departmental objectives and standard operating procedures.
  • Collaborate with the laboratory management team to recruit shared staff and oversee training for new hires in accessioning and laboratory support tasks.
  • Work closely with Clinical Operations to manage sample logistics and monitor incoming specimens for testing related to investigator-initiated trials and other company-sponsored research.
  • Develop and maintain standard operating procedures (SOPs) pertinent to specimen intake and accessioning.
  • Address employee-related issues concerning accessioning and laboratory support, working with laboratory supervisors and management to find resolutions.
  • Contribute to performance evaluations for accessioning staff.
  • Establish and monitor quality and operational metrics; present findings in weekly, monthly, and quarterly meetings, and recommend process enhancements.
  • Investigate and document accessioning discrepancies and non-conformances; initiate and manage corrective actions as necessary.
  • Ensure compliance with all relevant regulatory agency standards.
  • Perform additional duties as assigned.

Qualifications:

  • Bachelor's degree in life sciences or a comparable combination of educational and professional experience.
  • Demonstrated ability to work collaboratively across functions on company initiatives, with experience leading improvement projects to enhance process efficiencies.
  • 3-5 years of relevant experience in a clinical laboratory setting, with a solid understanding of CLIA, CAP, and quality system principles related to specimen management.
  • A minimum of 2 years of supervisory experience in a CLIA laboratory, showcasing strong leadership skills to promote a high-performance, team-oriented environment.
  • Exceptional interpersonal and communication skills, both verbal and written, across technical and non-technical domains.
  • Proficient in computer applications, particularly Microsoft Office, with the ability to track key metrics and generate operational reports.
  • Proven leadership in task management with a record of achieving objectives on time.

Additional Information:

At CareDx, every individual plays a vital role in our mission to enhance the lives of organ transplant patients globally. We prioritize the well-being of our employees, enabling them to provide exceptional care to our patients.

Our comprehensive Total Rewards package includes:

  • Competitive base salary and performance-based incentives.
  • Health and wellness benefits, including a gym reimbursement program.
  • 401(k) retirement savings plan with company matching.
  • Employee Stock Purchase Plan.
  • Pre-tax commuter benefits.
  • And additional perks.

With innovative products that are positively impacting the lives of transplant patients today and a promising pipeline for the future, it is an exciting time to be part of CareDx.

CareDx, Inc. is an Equal Opportunity Employer and participates in the E-Verify program.