Scientific Director
Department: Toxicology
Reports to: Director, Laboratory Operations
Position Summary
The Scientific Director (Licensed) is responsible for basic personnel and resource management, direction of quality control, and client interaction. The incumbent will be responsible for ensuring that the Toxicology laboratory remains in compliance with CAP, CAP-FUDT and New York accreditation requirements.
Essential Job Duties and Responsibilities
1. Approves of the test method selection and validation.
2. Ensures that the proficiency test method-testing program is conducted in a timely manner, reviewed by appropriate staff, and approve of corrective action when a proficiency testing result is found to be unsatisfactory.
3. Establishes and monitors quality control to ensure that acceptable levels of analytical performance are maintained for each test system. Ensures that patient test results are reported only when the system is functioning properly.
4. Approves all corrective action and preventative action plans and procedure.
5. Approves job assignments and annual Performance and Development Review (PDR) to ensure that all personnel have the appropriate training and demonstrated performance for the type of testing offered.
6. Annually reviews Standard Operating Procedures for test systems.
7. Provides discussion of assay data for clients via personal interaction.
8. Provides clinical consultation to clients of the laboratory.
9. Ensures that test results include pertinent information required for interpretation.
10. Communicates matters about quality of test results and interpretation in relation to specific patient conditions.
Lab Management
1. Implements safety procedures applicable to the department(s); ensures they are clearly defined and strictly enforced through proper delegation to laboratory
supervisors. Reviews all safety procedure up-dates and revisions.
2. Ensures efficient operation of assigned departments; responsible for the policies on quality and accuracy of reporting of test results. Maintains appropriate communications both intra and inter-departmentally.
3. Ensures departments are in compliance with all applicable local, state and federal licensing regulations.
4. Develops and monitors budget in accordance with business objectives.
5. Develops organization and staffing plans to meet the business objectives of the company.
6. Responsible for developing staff to reach the highest level of professional standards through participation in training, scientific meetings, workshops and in-house lectures.
7. Participates and leads lab management initiatives to improve employee satisfaction.
Scientific
1. Develops and implements short and long range, medical and scientific objectives for assigned departments. Delegate and oversee duties of scientific staff as necessary.
2. Responsible for the on-going research and development of new assays, troubleshooting and/or improvements of current assays.
3. Participates, as needed, in the formulation and coordination of sales and marketing objectives and programs. Assists in the identification of new clients and new services. Functions as a liaison between laboratory clients and the sales and marketing organization. Provides assistance to Sales and Marketing in terms of writing technical brochures and, as required, give lectures to clients and sales representatives.
4. Serves as representative to the scientific community via services, publications, presentations, etc.
5. Liaison to scientific community and biotechnology industry.
Physical Demands
Ability to work in a stressful environment.
Qualifications
Experience, Education, and Licensure
PH.D in Toxicology, Biochemistry, Chemistry, Pharmacology or Forensic Science
D-ABFT, D-ABCC or NRCC-Toxicological Chemist certification. Minimum of (8) years progressive laboratory experience in a Toxicology lab, including at least five (5) years experience in a management position. Qualified as an expert witness in a court of law.
Knowledge, Skills and Abilities
Knowledge of CAP regulations that pertain to Forensic and Clinical Toxicology.
Knowledge of Immunoassay, GC, GC/MS, HPLC, AA, ICP/MS and LC-MS/MS.
Demonstrated commitment to customer satisfaction and quality processes.
Ability to work with minimal supervision.
Must exhibit good verbal and written communication skills and organizational abilities.