Director, Laboratory Services - Infectious Disease Testing
Location: San Antonio, Texas
Salary: $145,000 - $170,000 + bonus + excellent benefits + relocation assistance
Position Overview: Lead and manage laboratory services to ensure efficient operations that meet or exceed quality standards. Implement Lean Six Sigma or other methodologies to drive process improvements, enhance lab performance, and optimize resource allocation. Oversee technical activities related to Infectious Disease and Donor Acceptability Testing, including pre-analytical, serological, nucleic acid, and ancillary testing.
Key Responsibilities
Operational Excellence:
- Ensure smooth and efficient laboratory operations.
- Utilize Lean Six Sigma or similar methodologies for process improvements.
- Optimize resource allocation to enhance lab performance.
Technical Oversight:
- Oversee technical activities related to Infectious Disease and Donor Acceptability Testing.
- Manage pre-analytical, serological, nucleic acid, and ancillary testing processes.
Growth Mindset & Innovation:
- Drive operational improvements and foster a results-oriented culture.
- Lead innovation initiatives and seek opportunities for cost efficiencies.
- Implement game-changing solutions to enhance laboratory operations.
Team Development & Collaboration:
- Lead and mentor a multidisciplinary team.
- Foster a culture of learning, flexibility, and open communication.
- Provide growth opportunities through education programs and support professional development.
- Guide team efforts in implementing new testing protocols and ensuring regulatory compliance.
Executive Presence & Communication:
- Serve as a credible and influential leader.
- Effectively communicate the company's vision internally and externally.
- Simplify complex technical and operational concepts for stakeholders, including regulatory bodies, staff, and senior leadership.
- Ensure alignment with the company's broader vision.
Requirements
- Requires a bachelor's degree from an accredited four-year university from a biology, microbiology, chemistry, medical technology, clinical laboratory science, or related field. Master's Degree preferred.
- +7 years of laboratory experience.
- +5 years of experience/training in infectious disease high-complexity testing.
- +5 years of management experience within laboratory operations with a minimum of 2 years supervising high-complexity testing.
- Must have strong expertise in regulatory requirements within clinical and diagnostic laboratory environments, ensuring strict compliance with industry standards.
- Must have excellent communication, leadership, and analytical skills, with a focus on strategic decisionโmaking and operational efficiency.
- Technical Expertise: The candidate must demonstrate proficiency in testing platforms, including a thorough understanding of serology, immunoassay, and testing for bloodborne infections such as hepatitis B, hepatitis C, and HIV.
- Management Experience: The candidate should have experience managing or directing a high-volume, high-speed, multi-shift production laboratory. This includes proven capabilities in automation related to Donor Screening tests (e.g., NAT, VMT). Responsibilities include operating within budget constraints, meeting and exceeding testing turnaround times, ensuring employee and lab performance, and staff development.
- Regulatory Compliance: The candidate should have participated in, and preferably led, multiple regulatory inspections, including those by CLIA, CAP, FDA, and others. These inspections should be related to registration, accreditation, or licensure rather than mock inspections. The position requires ensuring compliance with various regulatory standards, including FDA, CLIA, CAP, GMP, AABB, ISO, EU, and others.
