Position Summary:

The Clinical Laboratory Manager will be responsible for management of the laboratory operations in support of clinical sample testing, such as in vitro diagnostics (IVD), companion diagnostic (CDx) development, and bioanalytical testing. This individual will be responsible to ensure all regulated laboratories activities are performed in accordance with the appropriate regulatory documentation and oversight, ensure all study documentation is complete, accurate and adheres to appropriate regulatory compliance, GXP, IVD, LDT, CLIA.. The position requires extensive technical background and clinical/regulatory experience running clinical assay development and validation in highly regulated environment. a natural aptitude for keeping track of multiple critical priorities and strong planning and communication skills.

Essential functions of the job include but are not limited to:

Lab Operation

• Collaborate with Project Managers, Operation Management, and Scientific Leads, to effectively prioritize and communicate daily activities for team members in order to achieve analytical demand
• Serve as a liaison for the scientific leads to help support organization of tasks and requirements prior to testing and escalation to appropriate parties for to address identified gaps that have potential impact to scheduled work
• Responsible to ensure all new laboratory work has the appropriate documentation (such as protocols, SOPs, etc..) and reagent in place and the assigned laboratory staff are appropriately trained, and training documented to participate on the studies they are assigned to.
• Responsible for maintaining Critical Reagent Inventory (such as vector, negative/positive controls) and Equipment Performance Qualification as needed.
• Direct experience in assay control tracking and QC trending for ongoing assays, using established KPIs for each project.
• Ability to clearly communicate operational information and issues to leadership and effectively manage their expectations.
• Author and review technical documentation including software validation protocols, development plans, and risk management plans etc.

Quality Management

• Assist Sr. Lab Operation Management to ensure quality delivery of laboratory services under Precision’s ISO 15189, CAP/CLIA (NYS certified facility) and GXP
• Drive Laboratory Process Improvement
• Author and report non-conformity events as necessary.
• Assist internal and external clients and collaborators in the design and implementation of studies supporting the product development process through all phases of design control.
• Manage cross-functional internal teams by driving business timelines and all key performance indicator deliverables.
• Resolve and assist in resolution of lab quality issues.

Business Development

• Evaluate contract/project budgets and report unexpected variances to department head.
• Participate in writing scientific proposals and preparing budgets.
• Coordinate the development and implementation of new laboratory projects.

Qualifications:

Minimum Required:

• Requires a minimum of 12 years of related experience with a Bachelor’s degree or
• 8 years and a Master’s degree or
• PhD with 5 years’ experience; or equivalent experience

Other Required:

• Direct experience working in regulated environments such as GXP, GMP, CLIA/CAP
• Must be able to read, write, speak fluently and comprehend the English language

Preferred:

• Experience working with cellular assays in a regulatory environment is highly preferred