Associate Director NGS Lab Operations

Predicine, Inc•Hayward, CA

12h

About The Position

We are seeking an experienced and highly qualified laboratory leader to oversee our Next-Generation Sequencing (NGS) laboratory operations. This role is responsible for managing laboratory operations, equipment and reagent oversight, regulatory compliance, and serving as a CLIA Technical Supervisor under a high-complexity testing environment. The successful candidate will act as a delegate of the CLIA Laboratory Director and must hold an active Clinical Laboratory Scientist (CLS) license. This individual will ensure operational excellence, regulatory compliance, and the integrity of clinical testing and reporting processes.

Requirements

Active Clinical Laboratory Scientist (CLS) license (State of California preferred if applicable).
Meets CLIA requirements for Technical Supervisor of high-complexity testing (42 CFR 493.1449).
Bachelor’s degree or higher in Medical Technology, Clinical Laboratory Science, Molecular Biology, or related field.
Minimum7+ years of clinical laboratory experience, including NGS or molecular diagnostics.
Minimum 3–5 years of laboratory management or supervisory experience.
Direct experience in CLIA-regulated high-complexity laboratoryenvironment.
Demonstrated experience reviewing and approving clinical test records.
Strong understanding of NGS workflows and instrumentation.
Experience with laboratory equipment validation and maintenance programs.
Proficiencyin laboratory information systems (LIS) and documentation control systems.
Strong knowledge of quality systems (CAPA, change control, deviation management).
Ability to interpret and apply regulatory requirements.
Strong decision-making and accountability.
Excellent documentation discipline and attention to detail.
Clear and effective communication skills.
Ability to balance regulatory rigor with operational efficiency.
High integrity and quality mindset.