Position SummaryThe Manager - Molecular Training & Operations is responsible for the technical components of the Molecular Lab within clinical business.
Job Responsibilities- Provides technical oversight of protocol execution and hands-on training for the molecular team by developing technical training program modules for current and new assays.
- Ensures that all team members are provided with complete process and theory training.
- Develops and updates SOPs as needed and monitors operational function on a regular basis.
- Works closely with the molecular team as well as external vendors to provide support in technical troubleshooting on instruments and testing protocols.
- Monitors department metrics and performance of procedures, quality control, and production efficiency and provides data to senior leadership on a regular basis.
- Works with client facing teams to resolve/explain technical or operational issues.
- Works closely with cross functional team members during new product transfer to ensure that all quality and operational details are discussed and implemented during validation.
- Focus on the maintenance and operation of protocols and instrumentation as well as planning the arrival and placement set up of any new or relocated equipment.
- Work closely with the quality and regulatory teams to performance qualify any new or relocated equipment.
- Assist in creation of requirements for LIMS improvement and subsequent user acceptance testing.
- Support compliance to all applicable regulatory and standard requirements (FDA, CLIA, NYS, CAP, ISO, etc.).
- Consult with the Laboratory (Medical) Director and other professional on staff, as needed.
- Make recommendations regarding hiring, discipline and promotion of subordinates; authorizes leave and overtime; evaluates and rates employee performance.
- Maintain confidentiality of all patient information in accordance with federal, state and local guidelines and regulations.
- Represent the Molecular department at Management Review meetings.
- Develop, train and mentor staff.
- Supports the general supervisor in achieving compliance with FDA, CLIA, CAP, NYS DOH and ISO 15189.
- This position has been delegated the responsibility of assessing employee competencies.
- Accepts other duties as assigned
Required Qualifications- Bachelor's or Master's degree in a chemical, biological, clinical or medical laboratory science, or medical technology from an accredited institution.
- 4+ years of laboratory experience in high-complexity patient testing, 1 of which is in molecular pathology methods.
- 1+ years leadership experience within a clinical laboratory setting.
Preferred Qualifications- Master's degree in a chemical, biological, clinical or medical laboratory science, or medical technology from an accredited institution.
- 1+ years experience at Caris Life Sciences.
- Demonstrate clear ability to explain previous molecular assay experience, including the function of positive/negative controls, sample results, and data interpretation.
- Possess relevant molecular skill set consisting of molecular fundamentals such as: RNA and DNA extraction, PCR, reverse transcription, and gel electrophoresis. Experience with real-time PCR, microarray, fragment analysis, Sanger sequencing, and Next Generation Sequencing preferred.
- CLSp(MB), MB(ASCP) certification.
Physical Demands- Must possess ability to sit, stand, and/or work at a computer for long periods of time.
- May have exposure to blood-borne pathogens, extreme temperatures, high noise levels, fumes and biohazardous material/chemicals including formalin in the lab environment.
- Visual acuity and analytical skill to distinguish fine detail. Ability to pass a visual color discrimination test.
Training- All job specific, safety, and compliance training are assigned based on the job functions associated with this employee.
Other- This position may require periodic travel and some evenings, weekends and/or holidays.
Conditions of Employment: Individual must successfully complete pre-employment process, which includes criminal background check, drug screening, credit check ( applicable for certain positions) and reference verification.
This job description reflects management's assignment of essential functions. Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time.
