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Key Responsibilities and Required Skills for Virology Lab Manager

💰 $115,000 - $160,000

ScienceBiotechnologyLaboratory ManagementVirologyHealthcare

🎯 Role Definition

As the Virology Lab Manager, you will be the operational and scientific cornerstone of our virology division. You are responsible for providing strategic leadership, technical oversight, and day-to-day management of all laboratory activities. This includes directing a team of laboratory personnel, ensuring the accuracy and timeliness of diagnostic and research testing, and maintaining strict compliance with all relevant regulatory standards (CLIA, CAP, etc.). You will drive the development and implementation of new assays, manage laboratory resources effectively, and foster a culture of safety, quality, and continuous improvement. Your expertise will be crucial in troubleshooting complex technical issues, guiding scientific direction, and ensuring the lab is prepared for all internal and external audits.

📈 Career Progression

Typical Career Path

Entry Point From:

  • Senior Research Scientist (Virology)
  • Clinical Laboratory Supervisor
  • Lead Clinical Laboratory Scientist (CLS/MLS) with a virology specialization

Advancement To:

  • Director of Laboratory Operations
  • Senior Manager, Clinical Diagnostics
  • Associate Director, R&D and Scientific Affairs

Lateral Moves:

  • Quality Assurance Manager (Diagnostics)
  • Clinical Science Liaison
  • Project Manager, Diagnostic Development

Core Responsibilities

Primary Functions

  • Provide dynamic leadership and day-to-day operational management for the virology laboratory team, including hiring, training, scheduling, performance management, and professional development.
  • Assume full responsibility as the Technical Supervisor for high-complexity testing, ensuring all procedures meet or exceed CLIA, CAP, and other relevant state and federal regulatory requirements.
  • Oversee the entire lifecycle of virological testing, from sample receipt and accessioning to data analysis, result interpretation, and final reporting, ensuring optimal turnaround times and accuracy.
  • Direct the development, optimization, and validation of novel molecular and serological assays for the detection and characterization of viral pathogens.
  • Author, review, and meticulously maintain all laboratory Standard Operating Procedures (SOPs), ensuring they are current, compliant, and consistently followed by all staff.
  • Manage the laboratory's comprehensive quality assurance (QA) and quality control (QC) programs, including proficiency testing, instrument calibration, and corrective action documentation.
  • Maintain the laboratory in a constant state of readiness for inspections by regulatory agencies (e.g., CAP, CLIA, FDA), acting as the primary point of contact during audits.
  • Champion and enforce a stringent biosafety program, ensuring all activities comply with BSL-2/BSL-3 safety protocols, chemical hygiene plans, and institutional guidelines.
  • Develop and manage the annual laboratory budget, including forecasting for capital equipment, reagents, consumables, and staffing needs to ensure financial accountability.
  • Act as the primary technical expert for troubleshooting complex assay failures, instrument malfunctions, and unexpected results, leading investigations to identify root causes and implement effective solutions.
  • Monitor key performance indicators (KPIs) for the laboratory, such as test volume, turnaround time, quality metrics, and cost-per-test, reporting findings to senior leadership.
  • Oversee the maintenance, calibration, and qualification of all laboratory instrumentation, coordinating with vendors for service and repairs as needed.
  • Manage laboratory inventory systems to ensure an uninterrupted supply of reagents and consumables, minimizing waste and preventing testing delays.
  • Foster a collaborative and positive work environment that encourages scientific curiosity, open communication, and a commitment to teamwork and excellence.
  • Stay abreast of the latest scientific advancements, emerging technologies, and changing regulatory landscapes in virology and molecular diagnostics to guide strategic laboratory improvements.

Secondary Functions

  • Collaborate closely with Research and Development, Clinical Affairs, and other cross-functional teams to support new product development and clinical trial testing.
  • Lead and participate in continuous improvement projects using methodologies like Lean or Six Sigma to enhance laboratory efficiency, workflow, and quality.
  • Prepare detailed scientific reports, technical summaries, and presentations for internal stakeholders and potential external partners or publications.
  • Provide expert consultation to clinicians, researchers, and public health officials regarding test selection, result interpretation, and technical capabilities of the laboratory.
  • Manage the laboratory's data within the Laboratory Information Management System (LIMS), ensuring data integrity, security, and proper integration with other systems.
  • Mentor junior scientists and technical staff, providing guidance on experimental design, data analysis, and career growth within the organization.
  • Participate in the strategic planning process for the laboratory services, identifying opportunities for expansion, new technology adoption, and service line development.

Required Skills & Competencies

Hard Skills (Technical)

  • Advanced Molecular Diagnostics: Expert-level proficiency in a wide range of molecular techniques including qPCR, RT-PCR, digital PCR, and Next-Generation Sequencing (NGS) for viral genomics.
  • Classical Virology Techniques: Hands-on experience with viral culture, virus isolation, plaque assays, and other cell-based virological methods.
  • Serological Assay Expertise: In-depth knowledge of developing and running serological assays such as ELISA, neutralization assays, and multiplex immunoassays.
  • Assay Development & Validation: Proven track record of developing, validating, and implementing complex laboratory-developed tests (LDTs) according to CLIA/CAP guidelines.
  • Regulatory Compliance: Deep understanding and practical application of laboratory regulations, including CLIA '88, CAP, ISO 15189, and state-specific requirements.
  • Biosafety Level 2/3 (BSL-2/BSL-3): Demonstrable experience working in and managing operations within a BSL-2 or BSL-3 containment facility.
  • Laboratory Information Management Systems (LIMS): Proficiency in using and managing LIMS for sample tracking, results reporting, and quality management.
  • Instrumentation Management: Experience with the operation, maintenance, and troubleshooting of automated liquid handlers, nucleic acid extractors, and various analyzer platforms.
  • Budget and Resource Management: Skill in developing and managing departmental budgets, forecasting expenses, and optimizing resource allocation.

Soft Skills

  • Leadership & Mentorship: Exceptional ability to lead, inspire, and develop a high-performing team of scientific professionals.
  • Problem-Solving & Critical Thinking: Superior analytical and troubleshooting skills to resolve complex technical and operational challenges effectively.
  • Communication: Excellent written and verbal communication skills for conveying complex scientific information clearly to diverse audiences.
  • Attention to Detail: Meticulous and highly organized approach to ensure accuracy and compliance in all aspects of laboratory operations.
  • Project Management: Strong ability to manage multiple projects simultaneously, from conception to completion, on time and within budget.
  • Adaptability: Ability to thrive and lead effectively in a fast-paced, high-pressure, and evolving scientific environment.

Education & Experience

Educational Background

Minimum Education:

Bachelor's Degree in a relevant scientific discipline. Must meet CLIA requirements for a Technical Supervisor of high-complexity testing.

Preferred Education:

Master's Degree (M.S.) or Doctorate (Ph.D.) in Virology, Molecular Biology, Microbiology, or a related field.

Relevant Fields of Study:

  • Virology
  • Molecular Biology
  • Microbiology
  • Clinical Laboratory Science

Experience Requirements

Typical Experience Range:

A minimum of 6-8 years of progressive, hands-on experience in a clinical or research virology laboratory, including at least 3 years in a formal supervisory, lead, or management role.

Preferred:

Direct experience managing a high-complexity, CLIA-certified and/or CAP-accredited diagnostic laboratory is strongly preferred. A proven history of successful regulatory inspections and direct involvement in the development and validation of viral diagnostic assays will be highly valued.

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