Scientific Manager Jobs in Indiana (NOW HIRING)

JOB DESCRIPTION

Job Title: Scientific Director

Job Function: Laboratory Operations

Department: Laboratory Operations

FLSA Status (HR only): Exempt

Position Summary:

The Scientific Director serves as the Laboratory Director for the Company's high-complexity clinical and forensic drug testing laboratories and is responsible for laboratory-wide scientific and technical leadership, providing both technical and administrative support.

The Scientific Director is the individual designated to meet the qualification, authority, and responsibility requirements of the Laboratory Director under the Clinical Laboratory Improvement Amendments (CLIA), the College of American Pathologists (CAP) Forensic Drug Testing Accreditation Program, and various state licensure programs (including the New York State Department of Health). The Scientific Director covers the CLIA-defined responsibilities of Laboratory Director, Technical Supervisor, and Clinical Consultant, as further described below.

The Scientific Director is responsible for Cordant’s testimony support services and toxicology interpretation services.  Regular interaction with Cordant clients is required.

The Scientific Director reports to the Chief Operating Officer and works collaboratively with the Company's leadership team.

Essential Functions:

• Work with the executive leadership team to develop and expand the strategic plan for the laboratory.
• Develop and maintain systems that ensure the technical competency of laboratory personnel, as required by applicable accrediting and licensing agencies.  Work closely and collaboratively with the operations team to ensure these systems are consistently applied.
• Ensure the laboratory meets all standards and requirements of, and maintains, accreditation and licensure with the College of American Pathologists (CAP) Forensic Drug Testing Accreditation Program, Centers for Medicare and Medicaid Services (CMS)/CLIA, applicable state licensing agencies (including New York State Department of Health), and any other laboratory accreditation/licensing program that the company may obtain in the future.
• Ensure the laboratory maintains compliance with all proficiency testing programs.
• Ensure the laboratory maintains compliance with all Occupational Safety and Health Administration (OSHA) standards. 
• Direct and be accountable for the overall operation and administration of the laboratory, including the selection and monitoring of personnel who are competent to perform testing, record and report results, and, when necessary, implement remedial actions.
• Specify, in writing, the responsibilities and duties of each individual engaged in the performance of the pre-analytic, analytic, and post-analytic phases of testing, including consultant and Assistant/Technical Director staff, and ensure that each individual performs only those duties.
• Ensure the laboratory has a sufficient number of qualified personnel to perform and report test results appropriately, in accordance with the laboratory's testing volume and complexity.
• Ensure that policies and procedures are established for monitoring individuals who conduct testing to assure that they are competent and maintain their competency.
• Review, edit, and approve all laboratory procedures, maintenance manuals, protocols, QA/QC procedures and records, and other documents to ensure compliance with CLIA and other applicable regulatory agencies or accrediting/certifying bodies (CAP, state licensing agencies, etc.).
• Responsible for the laboratory's quality and continuous improvement process; develop, maintain, and monitor the laboratory's quality assurance program; act as a member of, and hold regular meetings for, the Quality Improvement Committee. Each laboratory has a Quality Assurance Manager, who reports to the Scientific Director.
• Ensure that a quality assessment program is established and maintained to identify problems and take corrective action, and evaluate the effectiveness of corrective actions.  While collaboration with the operations team is required for any CAPA, the Scientific Director is responsible for ensuring its completion and continued monitoring.
• With approval of the executive leadership team, spearhead and help implement special projects within the laboratory, including the ongoing evaluation of new technologies.
• Respond to questions about test results and interpretation of laboratory data, and provide related clinical/scientific consulting.  The Scientific Director has regular and ongoing communication with Cordant’s clients.
• Direct and actively participate in all research and development projects.  Collaborate with the operations team for implementation of completed R&D projects into production.  R&D staff report directly to the Scientific Director.
• Review, edit, and approve all instrument and system validations.  Important note: Cordant uses a proprietary internally developed Laboratory Information System, changes to which must be approved by the Scientific Director.
• Continually review procedures and protocols to improve turnaround time, lower costs, and improve the quality of the Company's testing services.
• Participate in the continuing education of laboratory staff through presentation of courses in pharmacology, medicinal chemistry, instrumental analysis, forensic toxicology, and related areas.  Similarly, participate in training sessions for Cordant’s clients on a variety of toxicology topics.
• Attend regional and national meetings and conferences related to the industry; represent the Company at seminars, industry meetings, and other appropriate technical forums.
• Actively participate in Laboratory Operations meetings.
• Serve as the Company's designated expert witness for legal proceedings, providing testimony in depositions, administrative hearings, and trials regarding laboratory findings; prepare expert reports and review case files in support of litigation.
• Serve as the primary toxicological consultant for the Company, providing interpretation of quantitative and qualitative drug testing results, including pharmacokinetic interpretation and correlation of findings with clinical or legal questions, for internal stakeholders and external clients.
• Ensure that laboratory personnel and, where applicable, referring clients are notified promptly of any significant deviations from established performance characteristics of a test.

Additional Duties:

• Special projects as assigned.
• All other duties as assigned.

Education and Experience:

The Scientific Director must meet the qualification requirements applicable to a Laboratory Director under CLIA, CAP FDT, and all state licensure programs held by the laboratory (including New York State), which include the following core requirements:

• An earned doctoral degree (Ph.D.) in biology, chemistry, pharmacology, toxicology, medical technology, or a related clinical/medical laboratory science field from an accredited institution; or licensure as a physician (MD/DO) meeting the applicable board-certification and experience requirements.
• Board certification required (allowable certifications are defined by HHS or New York State).
•  At least two (2) years of laboratory training and/or experience directing or supervising high-complexity testing, including appropriate experience in analytical forensic toxicology and the analysis of biological material for drugs of abuse.
• At least 20 continuing education (CE) credit hours in clinical laboratory operations covering the responsibilities of the laboratory director, as required to obtain and maintain applicable state and accreditation certifications.  (Note: This requirement does not apply if continuously employed as a Laboratory Director since December 28., 2024.)
• Holds a Laboratory Director Certificate of Qualification with the State of New York that covers Forensic Toxicology, Clinical Toxicology and Clinical Chemistry (limited to specimen validity for drug testing).
• Required: demonstrated experience providing expert witness testimony in depositions, administrative hearings, and/or trials, along with training and/or experience in forensic applications of analytical toxicology sufficient to qualify the individual as an expert witness in forensic toxicology.
• Appropriate experience in a urine drug testing or similar high-complexity laboratory; experience in the analysis of alternate matrices (oral fluid, hair, blood) is desirable.

Note: The specific combination of degree, certification, continuing education, and experience required for an individual candidate depends on which pathway under CLIA, CAP, and/or New York State DOH the candidate qualifies under.

Knowledge, Skills, and Abilities:

• Expert ability to understand analytical techniques and laboratory procedures.
• Expert ability to understand laboratory instrumentation.
• Expert ability to understand certification and licensure requirements for CLIA, CAP, applicable state agencies (including New York State DOH), and other relevant regulatory bodies.
• Expert ability to understand the function of a Laboratory Information Management System (LIMS) and other laboratory computer systems.
• Expert ability to communicate scientific and technical ideas clearly, both verbally and in writing.
• Advanced ability to teach and train others.
• Expert ability to write technical procedures.
• Expert ability to write technical reports.
• Strong organizational, administrative, and leadership skills, with the ability to direct laboratory operations and personnel across multiple sites.
• Excellent customer service skills, as regular interaction with Cordant clients is required.
• Expert ability to testify effectively in depositions, administrative hearings, and trials, including withstanding cross-examination, and to translate complex toxicological and analytical findings for non-scientific audiences such as attorneys, judges, and juries.

Physical Requirements:

• Sitting and standing for long periods of time.
• Repetitive motions and/or prolonged computer use.
• Working at a fast pace, subject to many interruptions and both physical and mental stress.
• Occasional travel to laboratory sites, industry meetings, and conferences. #LAB123