The Molecular Laboratory Services Technical Director is responsible for managing overall molecular laboratory operations for Embry Health as directed and delegated by the Medical Director. The Molecular Laboratory Service Technical Director implements the directives and works under the direct supervision of the Medical Director, and in compliance with the Clinical Laboratory Technical Director. Ensures compliance with local, state, and federal requirements. Implements and maintains clinical practice standards and staff development. Provides oversight and technical consultant responsibilities in addition to technical performance responsibilities for molecular tests performed within Embry Health molecular laboratory service.
• Responsible for the overall management of the molecular laboratory including administrative, financial, compliance, quality improvement, technical, and personnel activities in accordance with established policies and standards.
• Develop, implement, perform and maintain clinical laboratory molecular service tests.
• Provide molecular laboratory technical support to all levels of laboratory staff, management and administration to ensure the best methods of operation, testing, reporting and quality are understood and followed at all levels.
• Manage molecular laboratory staff and ensure the highest levels of quality requirements are met.
• Assist the Medical Director in developing, implementing, and maintaining clinical and pathology molecular laboratory service standards.
• Identify and implement opportunities to improve department systems.
• Monitor workflow and turnaround time throughout the molecular laboratory services of Embry Health.
• Meet with Medical Director and/or Clinical Laboratory Technical Director as necessary to ensure compliance and coordination with laboratory administration and overall laboratory management.
• Develop and monitor quality control and quality assurance programs for molecular laboratory of Embry Health.
• Identify and correct problems that may adversely affect test performance or reporting of patient samples.
• Ensure specimen evaluations for molecular testing are accurate, thorough, and in compliance with accrediting requirements.
• Identify and implement procedures to improve the accuracy of laboratory evaluations.
• Provide medical molecular laboratory diagnostic and therapeutic information, products, and services by establishing specimen preparation procedures; developing and implementing analytical procedures; evaluating laboratory information; consulting with pathologist(s); reporting results according to protocols mandated by the regulatory agencies and the public health department.
• Maintain molecular laboratory equipment performance by establishing quality standards; developing operations, quality, and troubleshooting procedures; ensuring staff compliance; certifying instrument performance; arranging equipment replacement, service, and repair.
• Maintain and/or oversee medical molecular laboratory supplies inventory by monitoring inventory level; providing loss prevention and ensuring stock orders are sufficient for the testing needed.
• Maintain medical molecular laboratory productivity by monitoring workload of functional areas; identifying peak and slack periods; making operational or staffing adjustment.
• Maintain quality molecular results by developing a quality assurance system; consulting with pathologist(s); performing proficiency surveys; reviewing quality control and quality assurance programs; adjusting policy and procedures; generating reports; maintaining records.
• Ensure an efficient and functional medical molecular laboratory information system by identifying information needs and problems; recommending improvements; establishing priorities; testing; writing user manuals; training employees; maintaining security and confidentiality.
• Implement new programs, tests, methods, instrumentation, and procedures by investigating alternatives; preparing proposals; developing and performing parallel testing; monitoring progress.
• Maintain medical molecular laboratory staff by assisting Medical Director in recruiting, selecting, orienting, and training department employees.
• Maintain professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; participating in professional societies.
• Comply with state and professional continuing education licensure requirements by providing in-service and/or educational programs; monitoring outcomes.
• Resolve problems by consulting with pathologists, other laboratory managers, technical coordinators, laboratory directors, physicians, nurses, and other health care professionals.
• Ensure effective communication between laboratory staff, laboratory management, clinic management, medical directors, and administration through meetings, clinic visits or laboratory review.
• Perform the duties of Technical Consultant as defined by CLIA regulations for molecular laboratory.
• Takes on special projects or other assignments and completes them within timeframe.
• Meet and consult with Laboratory Medical Director for policies, procedures, forms, instrumentation, equipment, supplies, and LIS.
• Promotes standardization throughout the laboratory system.
Knowledge, Skills & Abilities:
KNOWLEDGE, SKILLS & ABILITIES:
• Knowledge of principles and techniques of clinical and pathology molecular laboratory testing procedures (i.e. DNA/RNA extraction, DNA/RNA library preparation; NGS, Target amplification, Quantitative PCR/rtPCR, and other molecular techniques).
• Knowledge of human genetics, NGS, and genotyping.
• Knowledge of medical terminology, communicable diseases, and environmental health issues.
• Knowledge of laboratory regulations, including quality control of media, reagents, and equipment, laboratory safety, laboratory documentation requirements, sterilization requirements, and laboratory equipment.
• Knowledge of applicable testing techniques.
• Knowledge of planning, budgeting, quality control, customer service, and supervision.
• Critical Skills
• 4+ yrs. experience in a clinical laboratory setting
• Experience with genetics or molecular biology techniques including DNA and RNA library preparation, Target amplification, and Next Generation Sequencing (NGS).
• Bench skills, including Illumina Workflows (Amplicon, Exome, Targeted RNA, mRNA-Seq, Whole Transcriptome, TargetRich (PGx)
• Prior experience with Illumina NextSeq 500; Illumina MiSeq v2; QuantStudio 3, Tecan Infinite 200 Pro; Agilent Tapestation 2200/4200; Biomek FX; QIAGEN QIACube; Hamilton Star; KingFisher Flex highly preferred
• Prior experience with CLIA/CAP laboratory and/or genetic company is highly preferred.
• Knowledge of HIPAA and laboratory SOPs, regulatory and safety procedures.
• Attention to detail and accuracy are crucial for the position.
• Ability to work independently and also in a collaborative environment.
• Ability to multitask and prioritize laboratory and data analysis tasks.
• Strong interpersonal skills and the ability to successfully complete projects.
• Must have Medical Technologist experience with a preference for generalist experience and/or technical consulting experience
• Expertise in CLIA (federal) regulatory guidelines
• State specific regulatory standards and accreditation organization standards to include COLA and CAP
• Skill in performing molecular laboratory tests (i.e. DNA/RNA extraction, DNA/RNA library preparation; NGS, Target amplification, Quantitative PCR/rtPCR, and other molecular techniques).
• Skill in project planning, laboratory operations, and budgetary control.
• Skill in using computers for database management, testing, and record-keeping functions.
• Experience as a laboratory supervisor, manager or technical consultant desired.
• Ability to communicate appropriately, both orally and written.
• Ability to collaborate effectively with health care team.
• Ability to recognize and resolve hazardous conditions.
• Ability to perform mathematical calculations.
• Ability to demonstrate full range of motion, manual dexterity, and eye–hand coordination in use of equipment and instruments.
Qualifications & Requirements:
EDUCATION & EXPERIENCE:
• Doctoral or Master's Degree in a laboratory science and have a minimum of one year of lab training or experience in the specialty of non-waived testing in the areas of laboratory service of responsibilityAND
• 4 - 6 years hospital management experience in area of expertise
• Minimum of 5 years’ experience in a high complexity laboratory and two years supervisor experience in a high complexity and CAP certified laboratory.
• Knowledge of CAP, CLIA, and other local, state, federal regulations
• Technologist in Molecular Biology, MB (ASCP)
• Special Analyst, Molecular Diagnostics (State of AZ Medical Board)
• Additional related Degrees/Certifications preferred
• Must be willing and able to lift up to 25 pounds.