Primary Technical Leader

Marshall University•Huntington, WV

2d•Onsite

About The Position

The Primary Technical Leader (PTL) is the highest technical authority for forensic DNA casework at MUFSC, accountable for the scientific integrity, technical validity, and regulatory compliance of all casework within the designated scope of technical authority. The core of the position is STR and Y-STR analysis by capillary electrophoresis, which is required at all times. Technical authority over massively parallel sequencing (MPS) may be added to the position by formal designation. Technical Leader designations are technology-specific and are granted, documented, and withdrawn independently by the Laboratory Director of Operations. The MPS Technical Authority designation (MPSTA) denotes a scope of technical authority, not a separate position, and may be held by the same individual who holds the Primary Technical Leader position. Addition of the MPSTA designation requires the education and experience specified in the MPS Technical Authority profile, met and documented before the designation takes effect. The PTL holds continuous technical authority over the capillary electrophoresis workflow, from evidence handling through final report, including CODIS profile eligibility and quality control prior to release for upload. DNA quantification by real-time PCR is the defined branch point: when a case moves to sequencing and the MPSTA designation is held by another individual, technical responsibility transfers after quantification and formal acceptance into the sequencing workflow. When both are held by the same individual, acceptance into the sequencing workflow is still recorded, but no transfer of technical authority occurs. The PTL sets technical direction, approves methods, resolves complex scientific issues, and ensures all analysis is performed in accordance with validated methods, FBI Quality Assurance Standards (QAS), ISO/IEC 17025, and applicable legal and regulatory requirements. The Primary Technical Leader is the laboratory’s Technical Leader of record and holds the full authority and minimum responsibilities across all technologies within the laboratory’s scope of accreditation. Where a technology-specific scope of technical authority is designated to another individual, such as the MPS Technical Authority designation, that designation constitutes a documented delegation of day-to-day technical authority within the designated workflow. The PTL retains overall accountability for the technical operations of the laboratory, including all delegated scopes, and retains the authority to initiate, suspend, and resume technical operations across those scopes.

Requirements

STR and Y-STR analysis by capillary electrophoresis
Education and experience specified in the MPS Technical Authority profile (if MPSTA designation is added)
Continuous technical authority over the capillary electrophoresis workflow
Technical Leader of record for the laboratory
Full authority and minimum responsibilities across all technologies within the laboratory’s scope of accreditation
Overall accountability for the technical operations of the laboratory, including all delegated scopes
Authority to initiate, suspend, and resume technical operations across delegated scopes
Independent technical authority within each designated scope of accreditation
Coordination with any other designated Technical Leader, the Quality Manager, and the LDO for continuity, compliance, and cross-technology integration
Final technical authority over casework workflows and interpretations
Final technical authority over the acceptability of profiles provided to the uploading agency for CODIS
Technical acceptance of instruments and platforms
Approve technical specifications for outsourcing agreements
Identify and approve technical need for kits, supplies, and consumables
Provide technical consultation on case acceptance, scope, and feasibility
Provide technical input and consultation on case triage and assignment
Authorize requests for additional evidence or information
Verify and approve case submission and acceptance
Technical supervision of evidence examination and screening, isolation, extraction, quantification, amplification, capillary electrophoresis, and genetic characterization of biological samples
Authorize technical transfer to the MPS Technical Authority
Evaluate, approve, and maintain methods and their validations
Propose and assess new or modified procedures
Establish and maintain interpretation guidelines
Resolve complex analytical and interpretive challenges
Lead interpretation of complex profiles
Render final technical determinations on analytical and interpretive issues
Hold technical accountability for approval of forensic, relationship, and database reports
Determine CODIS eligibility of profiles
Verify genotype concordance
Serve as the technical point of contact with the uploading agency
Coordinate reporting consistency and case integration
Perform or oversee technical review and approval of casework and reports
Decide on technical deviations, alternative approaches, and non-routine issues
Support court preparation and consult on analyst testimony
Review, approve, and oversee training, proficiency testing, and analyst qualification
Set and enforce competency requirements
Provide technical guidance and supervision
Authorize DNA Technicians to execute specific procedures and instrument operations
Serve as the primary technical authority during internal and external audits and accreditation assessments
Review audit documentation
Approve technical corrective actions
Periodically review procedures
Perform other technical duties as assigned or coordinated

Nice To Haves

Technical authority over massively parallel sequencing (MPS) may be added to the position by formal designation.
Addition of the MPSTA designation requires the education and experience specified in the MPS Technical Authority profile, met and documented before the designation takes effect.

Responsibilities

Govern the technical operations of the designated technologies as the final technical authority for all related casework.
Define, approve, and enforce technical policies, procedures, and requirements within the scope of accreditation.
Authorize the start, suspension, or resumption of workflows in response to technical, quality, or safety concerns across all phases of analysis.
Provide technical acceptance of instruments and platforms before use in casework.
Approve the technical specifications for outsourcing agreements and outsourced services.
Identify and approve the technical need for kits, supplies, and consumables within the designated scope, in coordination with operations and finance.
Provide technical consultation on case acceptance, scope, and feasibility.
Provide technical input and consultation on case triage and assignment within the designated scope, in coordination with operational leadership.
Authorize requests for additional evidence or information when needed for technical reasons.
Verify and approve case submission and acceptance from a technical standpoint.
Maintain continuous technical authority over the capillary electrophoresis workflow, from evidence receipt through interpretation and final report.
Provide technical supervision of evidence examination and screening, isolation, extraction, quantification, amplification, capillary electrophoresis, and genetic characterization of biological samples.
Authorize technical transfer to the MPS Technical Authority when a case proceeds to sequencing, after quantification and formal acceptance into the sequencing workflow, when that designation is held by another individual.
Evaluate, approve, and maintain methods and their validations within the designated scope.
Propose and assess new or modified procedures using a risk-based, scientifically justified approach.
Establish and maintain interpretation guidelines, including analytical and stochastic thresholds and mixture criteria, and the criteria that distinguish routine from non-routine casework.
Resolve complex analytical and interpretive challenges.
Lead interpretation of complex profiles, including mixtures, low-template, degraded, and inhibited samples.
Render final technical determinations on analytical and interpretive issues, ensuring consistency, reproducibility, and compliance.
Hold technical accountability for approval of forensic, relationship, and database reports, including appropriate disclosure of limitations before issuance.
Determine CODIS eligibility of profiles generated by the laboratory, verify genotype concordance as internal quality control.
Serve as the technical point of contact with the uploading agency on profile eligibility, concordance, and resolution of database-related technical questions.
Coordinate reporting consistency and case integration when multiple technologies apply to a case.
Perform or oversee technical review and approval of casework and reports within the designated scope.
Decide on technical deviations, alternative approaches, and non-routine issues.
Support court preparation and consult on analyst testimony within the designated scope.
Review, approve, and oversee training, proficiency testing, and analyst qualification within the designated scope.
Set and enforce competency requirements, providing technical guidance and supervision so personnel maintain authorization and compliance.
Authorize DNA Technicians to execute specific procedures and instrument operations following documented training and competency assessment.
Serve as the primary technical authority during internal and external audits and accreditation assessments for the designated workflows, in coordination with the Quality Manager.
Review audit documentation, approve technical corrective actions, and periodically review procedures, including conflict-of-interest risk assessments.
Perform other technical duties as assigned by the Executive Director or coordinated through the LDO, provided they fit the designated technical authority and do not assume executive, quality system, or operational administration authority under the MUFSC Governance and Authority Framework.