Associate Director, Laboratory Operations

Location

Morrisville, NC | United States

Job description

SAGA Diagnostics is seeking an Associate Director, Laboratory Operations who will be responsible for the day-to-day management of the pre-analytic workflows including oversight of incoming biospecimens, accessioning and storage of biospecimens, freezer inventory and monitoring, preparing outbound shipments, and histology functions. Based out of our Morrisville, NC office, the Associate Director, Laboratory operations will contribute to processes leading to fast and accurate sample accessioning and efficient sample delivery, enabling rapid turnaround sample testing and real-time analysis. Their work will include communicating and collaborating with various departments with a spirit of continuous improvement. In general, the Associate Director, Laboratory Operations will need to be proactive, detail oriented, and collaborative.

KEY RESPONSIBILITIES: 

Laboratory Operations: 

• Develop and implement laboratory operations in alignment with company goals, objectives, and budget. 
• Demonstrate a strong understanding of implementation, documentation, and oversight of sample traceability processes including end to end chain of custody from sample order through reporting   
• Establish robust procedures to ensure shipment and tracking of biospecimen shipment through LIMS and specimen storage and preparation  
• Build and lead specimen biorepository operations  
• Ensure all samples are packed for shipment in compliance with regulatory agencies and company policy and procedures  
• Prepares Quality Event documentation, NCRs, and CAPAs to address quality issues   
• Oversee management of laboratory consumables, critical stock reagents, and materials. Negotiate service level agreements with vendors and suppliers ensuring predictable flow and availability of critical supplies.  
• Strategic acquisition of laboratory assets. Develop asset inventory system allowing tracking of asset status, service information, utilization, down-time, and other key analytics and metrics.  

People Management and Training: 

• Directly manage individuals in the following functions: Accessioning, Material Handling, Biospecimen Management, Histology, etc. to establish a modern laboratory operations function with a focus on compliance, efficiency, and improvement.  
• Proactively manage team and workflows to deliver on key metrics  
• Ensuring that all team members have been trained to use laboratory equipment, software, and supplies safely and efficiently.  

Cross-Team Collaboration: 

• Support the Lab manager with the implementation of new technical resources to improve on clinical specimen storage through LIMS   
• Lead laboratory compliance efforts in collaboration with laboratory compliance team and site leadership, including CAP, CLIA, NYS, OSHA, etc. 

• Lead implementation of new platforms and their integration into Lab operations and make recommendations to upper management for strategic growth opportunities.  
• Cultivate innovation by seeking opportunities to strengthen and improve existing services and operations. 

QUALIFICATIONS: 

We understand that people can gain experience in a variety of settings. We encourage candidates to review the key responsibilities and qualifications for the role and if you believe you have the necessary experience or transferable skills to fulfill the duties assigned, we encourage you to apply. 

• High School diploma required. Bachelor's degree in a related scientific discipline is preferred
• Minimum 8 years of relevant sample management experience in commercial laboratory, clinical research organization, biomedical institution, or similar.
• Experience in lab management (LIMS) and clinical specimen management systems are required
• Working knowledge of GxP, GCP, CAP, and CLIA regulations Must have demonstrated expertise in their scientific discipline, as well as a solid understanding of current CAP and GCLP standards.
• At least 5 year of people management experience
• Demonstrates teamwork by effective participation in multifunctional teams, motivate colleagues, build relationships with customers, and finding opportunities for collaboration
• Function as an effective and professional team member in diverse workgroups
• Excellent communication, planning and organization skills required

 
DETAILS: 

Reports to: VP Clinical Operations 
Primary Location and Work Arrangement: Morrisville, NC, On Site 
Preferred Start Date: March 25, 2024

ABOUT: 

About Saga Diagnostics: SAGA Diagnostics is a personalized cancer medicine and disease monitoring company focused on molecular genetic analyses of circulating tumor DNA and tissue biopsies. 

About the Saga Diagnostics Team: At Saga Diagnostics, we are passionate about the potential of our product and how it can make a tangible difference in the lives cancer patients. While we are a global company, our staff care deeply about each other and leverage their skills and expertise to move our work forward together. The work of Saga Diagnostics is dynamic and challenging, and we understand that our people are critical to our success.

Saga Diagnostics is an equal opportunity employer, fully committed to achieving a diverse and inclusive workplace that embraces and encourages applicants of every background. The company’s policy regarding equal employment opportunity means that all decisions regarding recruitment, hiring, benefits, wage and salary administration, scheduling, disciplinary action and termination will be made without unlawful discrimination on the basis of sex, gender, race, color, age, national origin, religion, disability, medical condition, genetic information, marital status, sexual orientation, gender identity or expression, citizenship status, pregnancy or maternity, veteran status, or any other status protected by applicable federal, state or local law. If you require reasonable accommodation in completing an application, interviewing, or otherwise participating in the employee selection process, please direct your inquiries to [email protected] . 

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