Laboratory Operations Director - Molecular Background
Our client is seeking a high level Laboratory Operations Director that has a minimum of 5 years experience in molecular diagnostics laboratory, with additional experience in clinical diagnostics testing and operations. This is a senior leadership role. Excellent compensation and benefits package, relocation assistance will considered. Location is ANN ARBOR, MICHIGAN and PHD is required.
In this position the Laboratory Operations Director will oversee daily operations of the Molecular Diagnostics Laboratory which performs a variety of medical oncology molecular assays but focuses on Next Generation Sequencing (NGS) of cancer tissue. Responsibilities for the position include supervising daily operations and personnel for the molecular interrogation of the cancer sample, performing duties of a technical specialist, overseeing clinical testing and results reporting in all areas where training and verification of competency are attained, trouble shooting analytical problems in the analysis of NGS of cancer tissues on a daily basis. Primary responsibilities include overseeing the successful implementation of new NGS assays, quality control, technical troubleshooting, assisting in the oversight and training of technical and non-technical staff and ensuring a high quality of services under the supervision of the Laboratory Management.
With minimal assistance, supervises the day to day operations of a CLIA-certified, CAP-accredited clinical NGS diagnostics lab as well as some Immunohistochemistry work.
Is responsible for accepting Paradigm's R & D tests and oversees the implementation and successful day to day running of the assay, writing, and implementing clinical lab procedures in accordance with CLIA and CAP policies.
Maintains all aspects of QC and QA relevant to the CAP certification standards.
Supervise Laboratory operations including medical technologists, troubleshoots assay failures, and make suggestions and/or corrections.
Interact with clients and clinicians to answer questions on appropriate testing.
Monitors work flow, assay volumes, TAT, set-ups, reagents, SOPs, validation etc.
Assists Lab Manager with preparation of budgets, purchases, equipment, and supplies.
Performs other job-related duties as assigned by the CEO.
Reports directly to the Laboratory Medical Director and the CEO
ESSENTIAL DUTIES
In order of importance
1. Together with the Lab Medical Director, play lead role in overseeing the implementation of new molecular tests and the day to day operations of those tests.
2. Manage the profitability of laboratory operations by achieving or exceeding budgeted cost of analytical testing services (e.g. COGS).
3. Assist with the development, optimization, and clinical validation of new tests utilizing molecular techniques such as NGS, PCR
4. Assure quality control criteria are met including adherence to state and federal regulations.
5. Oversight and participation in the performance of proficiency testing.
6. Assist in the development, evaluation, and implementation of new procedures and protocols.
7. Identify source and nature of test problems and make appropriate recommendation as to course of action.
8. Exercise judgment within defined procedures and policies to determine appropriate action.
9. Record, compile, create, and maintain accurate records and communicate summaries of laboratory results as needed. Field questions and concerns from physicians, nurses, and external laboratory staff.
10. Oversight of inventory management, and the efficient use of reagents and equipment
11. Oversight of the management of workflow to ensure efficient use of personnel and equipment.
12. Operate, calibrate, perform, and supervise routine maintenance on instrumentation. Perform instrument maintenance at the prescribed time and logs appropriately.
13. Oversee and if needed instruct and train new members of the laboratory staff, rotating residents, students, and physicians as needed.
14. Supervise molecular laboratory staff with testing development, day-to-day operations in connection with clinical assays and tests, as well as policies, processes and protocols as they relate to testing and development. Take action on personnel decision activities
15. Is involved in performance appraisal processes of molecular personnel.
16. Oversee daily lab operations of molecular operations and testing in the absence of lab manager.
ESSENTIAL BEHAVIORS
Build Trust:
Operate with transparency, no hidden agenda; place confidence in colleagues, give proper credit to others. Follow through on agreed upon actions. Treat sensitive or confidential information appropriately. Keep emotions in the laboratory and ancillary staff under control. Exhibit ethical and moral behavior in everyday business conduct.
Foster Communication:
Demonstrate ability to carefully listen to others at all levels of the organization. Seek and listen to feedback and be approachable. Express thoughts and ideas effectively. Display and promote cross cultural sensitivity.
Display Stewardship:
Understand business implications of decisions. Conserve organization resources. Look for ways to improve and promote quality. Take personal responsibility. Use resources in an efficient and cost-effective manner.
MINIMUM POSITION QUALIFICATIONS
Must Have PHD Appropriate education and/or experience may be substituted on equivalent basis
Education Doctor of Philosophy in a relevant biological science or biochemistry
Clean Criminal Background requiredEstimated Salary: $20 to $28 per hour based on qualifications.
In this position the Laboratory Operations Director will oversee daily operations of the Molecular Diagnostics Laboratory which performs a variety of medical oncology molecular assays but focuses on Next Generation Sequencing (NGS) of cancer tissue. Responsibilities for the position include supervising daily operations and personnel for the molecular interrogation of the cancer sample, performing duties of a technical specialist, overseeing clinical testing and results reporting in all areas where training and verification of competency are attained, trouble shooting analytical problems in the analysis of NGS of cancer tissues on a daily basis. Primary responsibilities include overseeing the successful implementation of new NGS assays, quality control, technical troubleshooting, assisting in the oversight and training of technical and non-technical staff and ensuring a high quality of services under the supervision of the Laboratory Management.
With minimal assistance, supervises the day to day operations of a CLIA-certified, CAP-accredited clinical NGS diagnostics lab as well as some Immunohistochemistry work.
Is responsible for accepting Paradigm's R & D tests and oversees the implementation and successful day to day running of the assay, writing, and implementing clinical lab procedures in accordance with CLIA and CAP policies.
Maintains all aspects of QC and QA relevant to the CAP certification standards.
Supervise Laboratory operations including medical technologists, troubleshoots assay failures, and make suggestions and/or corrections.
Interact with clients and clinicians to answer questions on appropriate testing.
Monitors work flow, assay volumes, TAT, set-ups, reagents, SOPs, validation etc.
Assists Lab Manager with preparation of budgets, purchases, equipment, and supplies.
Performs other job-related duties as assigned by the CEO.
Reports directly to the Laboratory Medical Director and the CEO
ESSENTIAL DUTIES
In order of importance
1. Together with the Lab Medical Director, play lead role in overseeing the implementation of new molecular tests and the day to day operations of those tests.
2. Manage the profitability of laboratory operations by achieving or exceeding budgeted cost of analytical testing services (e.g. COGS).
3. Assist with the development, optimization, and clinical validation of new tests utilizing molecular techniques such as NGS, PCR
4. Assure quality control criteria are met including adherence to state and federal regulations.
5. Oversight and participation in the performance of proficiency testing.
6. Assist in the development, evaluation, and implementation of new procedures and protocols.
7. Identify source and nature of test problems and make appropriate recommendation as to course of action.
8. Exercise judgment within defined procedures and policies to determine appropriate action.
9. Record, compile, create, and maintain accurate records and communicate summaries of laboratory results as needed. Field questions and concerns from physicians, nurses, and external laboratory staff.
10. Oversight of inventory management, and the efficient use of reagents and equipment
11. Oversight of the management of workflow to ensure efficient use of personnel and equipment.
12. Operate, calibrate, perform, and supervise routine maintenance on instrumentation. Perform instrument maintenance at the prescribed time and logs appropriately.
13. Oversee and if needed instruct and train new members of the laboratory staff, rotating residents, students, and physicians as needed.
14. Supervise molecular laboratory staff with testing development, day-to-day operations in connection with clinical assays and tests, as well as policies, processes and protocols as they relate to testing and development. Take action on personnel decision activities
15. Is involved in performance appraisal processes of molecular personnel.
16. Oversee daily lab operations of molecular operations and testing in the absence of lab manager.
ESSENTIAL BEHAVIORS
Build Trust:
Operate with transparency, no hidden agenda; place confidence in colleagues, give proper credit to others. Follow through on agreed upon actions. Treat sensitive or confidential information appropriately. Keep emotions in the laboratory and ancillary staff under control. Exhibit ethical and moral behavior in everyday business conduct.
Foster Communication:
Demonstrate ability to carefully listen to others at all levels of the organization. Seek and listen to feedback and be approachable. Express thoughts and ideas effectively. Display and promote cross cultural sensitivity.
Display Stewardship:
Understand business implications of decisions. Conserve organization resources. Look for ways to improve and promote quality. Take personal responsibility. Use resources in an efficient and cost-effective manner.
MINIMUM POSITION QUALIFICATIONS
Must Have PHD Appropriate education and/or experience may be substituted on equivalent basis
Education Doctor of Philosophy in a relevant biological science or biochemistry
Clean Criminal Background requiredEstimated Salary: $20 to $28 per hour based on qualifications.
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