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Molecular & Validation Manager
Edison, NJ
Posted 4/8/2025
The Molecular & Validation Manager is responsible for overseeing the daily operations of the Molecular Department, ensuring high-quality molecular diagnostic testing and regulatory compliance. This role provides leadership in validation studies, quality assurance (QA), and quality control (QC), while optimizing laboratory workflows and personnel management. The Molecular & Validation Manager works closely with senior leadership to drive operational efficiency, maintain regulatory adherence, and promote continuous improvement in molecular diagnostics.
 
Working Relationships1. Reports To: Vice President of Technical Support2. Directly Supervises: Molecular Laboratory Staff3. Indirectly Supervises: Not Applicable4. Type of Supervision Received: General Direction5. Internal Relationships: Extensive6. External Relationships: Moderate
 
 
Essential Duties & Responsibilities
 
  • Oversee daily molecular laboratory operations, including workflow optimization and resource management.
  • Ensure timely and accurate molecular diagnostic testing in compliance with CAP, CLIA, and state regulations.
  • Develop and implement operational strategies to improve efficiency and reduce turnaround time.
  • Supervise and support laboratory staff, fostering a collaborative and high-performance work environment.
  • Manage inventory, supplies, and vendor relationships to ensure uninterrupted laboratory function.
  • Performs tasks of Molecular Technologist in his/her absence.
  • Lead validation studies for new molecular assays, instruments, and workflows.
  • Prepare and submit comprehensive validation reports for regulatory review and approval.
  • Ensure adherence to CAP, CLIA, and state regulatory requirements for all molecular testing procedures.
  • Maintain thorough validation documentation and update standard operating procedures (SOPs) as required.
  • Participate in regulatory inspections and audits, ensuring laboratory readiness and compliance.
 
 
Quality Assurance & Quality Control
  • Oversee QA/QC programs, including proficiency testing, internal audits, and compliance monitoring.
  • Implement and maintain robust quality control measures to ensure result accuracy and reliability.  
  • Identify and resolve non-conformances, deviations, and compliance risks.
  • Regularly review and revise SOPs to align with best practices and evolving regulatory standards.
 
Personnel Training & Development
  • Train and mentor laboratory personnel on validation procedures, QA/QC protocols, and regulatory requirements.
  • Conduct competency assessments and develop training materials to ensure staff proficiency.
  • Foster a culture of continuous learning, professional development, and teamwork within the department.
  • Provide performance feedback and participate in personnel evaluations.
 
Professional Requirements
  • Adheres to dress code, maintaining a neat and professional appearance.
  • Completes annual educational and continuing education requirements.
  • Ensures patient confidentiality at all times.
  • Maintains current knowledge of laboratory policies and regulatory requirements.
  • Reports on time and completes tasks within designated deadlines.
  • Represents the organization in a positive and professional manner.
  • Actively participates in departmental meetings and performance improvement initiatives.
  • Complies with all organizational policies and ethical business practices.
 
Education, Experience, and Skills Required
 
  • Bachelor’s degree in Molecular Biology, Clinical Laboratory Science, or a related field (Master’s preferred).
  • Minimum of 10+ years of experience in molecular diagnostics, including laboratory management and validation.
  • Strong knowledge of CAP, CLIA, and state regulatory requirements.
  • Proven experience in validation studies, data analysis, and regulatory reporting.
  • Excellent problem-solving, organizational, and leadership skills.
  •  Strong technical writing skills for preparing validation and regulatory reports.
  •  Ability to work in a high-complexity laboratory environment with a focus on continuous improvement.
  • ASCP certified Technologist in Molecular Biology 
  • Strong background in Cancer Genomics 
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