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GRAIL Manager, Clinical Laboratory Accessioning - RTP #3543 in Durham, North Carolina

GRAIL is a healthcare company whose mission is to detect cancer early, when it can be cured. GRAIL is focused on alleviating the global burden of cancer by developing pioneering technology to detect and identify multiple deadly cancer types early. The company is using the power of next-generation sequencing, population-scale clinical studies, and state-of-the-art computer science and data science to enhance the scientific understanding of cancer biology, and to develop its multi-cancer early detection blood test. GRAIL is headquartered in Menlo Park, CA with locations in Washington, D.C., North Carolina, and the United Kingdom. GRAIL, LLC is a wholly-owned subsidiary of Illumina, Inc. (NASDAQ:ILMN). For more information, please visit www.grail.com .

GRAIL is seeking a Clinical Laboratory Manager to support our clinical lab operations in RTP. The Manager, Clinical Laboratory Accessioning is responsible for the supervision of personnel and the overall operations of the Accessioning department including, but not limited to, specimen kit receipt process, order processing, sample processing, material return and management of associated documents and records.

The Manager, Clinical Laboratory Accessioning must also act as a liaison between the laboratory staff and key internal stakeholder groups including but not limited to Information Technology, Technical Operations, Bioinformatics, Software and Supply Chain groups. As such, the Manager must exhibit leadership skills such as good judgment, sound analysis and decision making, the ability to remain professional and composed under pressure, effective interpersonal relationships and the ability to optimally communicate across all levels of the laboratory and across departments. The Manager, Clinical Laboratory Accessioning will also be involved with shift scheduling, troubleshooting technical and non-technical problems, coaching and mentoring the laboratory staff, building effective teams, leading projects and meeting project results, and understanding and implementing laboratory goals. Given the wide variety of tasks involved in this position, the Manager must demonstrate the ability to analyze issues and make sound decisions in a timely manner, dedication to helping and motivating employees, the ability to respond to difficult issues quickly, fairly, and ethically, outstanding organizational skills, the ability to respond to change with flexibility and to adapt quickly to evolving circumstances, and excellent communication including utilizing various communication channels (team meetings, one on one etc.), proactively presenting team goals and priorities clearly, openly and objectively, and presenting changes, issues, and challenges in all directions of the organization.

Responsibilities

  • Provide day-to-day supervision of laboratory personnel and participate in daily Accessioning work as needed.

  • Be responsible for the daily pre-analytical operations of the laboratory including but not limited to scheduling, independently troubleshooting and resolving technical and non-technical high complexity problems.

  • Perform administrative duties including but not limited to writing employee performance evaluations and reviewing SOPs, protocols, QC forms, and equipment maintenance forms.

  • Coach and mentor Laboratory Associates including but not limited to providing mentorship and constructive feedback and assisting with the development of troubleshooting and judgment.

  • Collaborate with the product development and software engineering teams to enhance the LIMS capabilities for accuracy and scale.

  • Support and participate in internal and external audits and quality management activities to ensure laboratory compliance with the applicable quality standards and regulatory requirements.

  • Follow the laboratory's procedures for pre-analytical specimen handling and processing while participating in the continuous quality-improvement processes

  • Collaborate frequently with the analytical lab team to ensure appropriate flow of samples from accessioning into the analytical lab

  • Implement the laboratory's quality control policies and work with the Laboratory Supervisor, the Technical Supervisor on the laboratory’s quality control and quality assurance procedures, technical and non-technical troubleshooting and improvement procedures, and training and education programs

  • Ensure accurate documentation of quality control activities and maintenance are performed

  • Identify problems that may adversely affect accurate and efficient sample processing and either correcting the problems or immediately advising the analytical laboratory supervisor or manager

  • Lead projects pertaining to specimen stability, validation protocols, new products, new clinical studies, and other process improvements

  • Manage individual performance and employee performance, and deliver appropriate feedback when necessary

  • Drive a culture of collaboration and continuous improvement among team members that aligns with GRAIL’s values and mission

  • Write, revise, and review standard operating procedures

  • Possess a working knowledge of local, state, and federal laboratory regulations

  • Participate in laboratory inspections to ensure regulatory compliance

Preferred Qualifications

  • Bachelor of Arts or Science, or an equivalent combination of training and experience

  • Proven understanding of local, state, and federal laboratory regulations

  • 8+ years of Laboratory Accessioning experience

  • 3+ years of CAP/CLIA certified Laboratory Supervisory experience

  • Thorough understanding of CAP, CLIA, GLP, and GCP regulations

  • Strong communicator with ability to maintain open communication with internal employees, managers and customers as needed

  • Able to integrate and apply feedback in a professional manner

  • Able to prioritize and seek to results with a high emphasis on quality

  • Ability to work as part of a team

  • Ability to analyze and problem solve sophisticated issues that impact test performance

  • Strong analysis and problem-solving skills

  • Strong technical skills and job and industry knowledge

  • Strong project management abilities

  • Ability to proactively communicate consistently, clearly, and honestly

  • Strong automation and computing skills

  • High volume laboratory experience preferred

  • Training in molecular biology techniques preferred

PHYSICAL DEMANDS/WORKING ENVIRONMENT:

  • Hours and days may vary depending on operational needs

  • Standing or sitting for long periods of time may be necessary and may include weekends and holidays

  • May be exposed to hazardous materials, blood specimens and instruments with moving parts, heating or freezing elements, and high-speed centrifugation (Generally laboratory and customer service employees only)

  • Repetitive manual pipetting may be necessary

  • Some lifting (up to 25 pounds) may be necessary

Based on the role, colleagues may be eligible to participate in an annual bonus plan tied to company and individual performance, or an incentive plan. We also offer a long-term incentive plan to align company and colleague success over time.

In addition, GRAIL offers a progressive benefit package, including flexible time-off, a 401k with a company match, and alongside our medical, dental, vision plans, carefully selected mindfulness offerings.

GRAIL is an Equal Employment Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status. We will reasonably accommodate all individuals with disabilities so that they can participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us (https://grail.com/about/#contact-us) to request accommodation. GRAIL maintains a drug-free workplace.

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