Scientific Director Coagulation Lab at Vitalant in Pittsburgh, Pennsylvania

Job Description:

PRIMARY PURPOSE: 

Under minimal supervision this position is directly responsible for developing and implementing disease-focused molecular genetics techniques, including sequencing based methods, for the diagnosis and management of inherited disorders of hemostasis and thrombosis, such as congenital hemophilia A and B, von Willebrand’s disease, platelet function disorders and thrombophilias.  The candidate will participate as part of the management team in the direction of the coagulation reference laboratory, providing scientific/technical expertise.

DUTIES AND RESPONSIBILITIES:

Performs all assigned duties in compliance with internal SOPs and external regulations.  Brings compliance issues to the attention of management.

Assures quality customer service to all customers.

Responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, record and report test results promptly, accurately and proficiently, and assure compliance with the applicable regulations.

Directs and develops molecular genetic assays, including next generation sequencing, Sanger sequencing, restriction fragment length polymorphism (RFLP) and real-time PCR methodologies.  This includes developing new testing strategies, primarily for inherited disorders of hemostasis and thrombosis.

Maintains and innovates existing platforms for routine testing processes for hemostasis and thrombosis.  Provides guidance for technical troubleshooting and resolution of problems that arise in any testing process.  Ensures staff competent to perform test procedures, record and report test results promptly, accurately and proficiently, and ensure compliance with applicable regulations.

Oversees the implementation and maintenance of the Quality Assurance Program to ensure high quality services to all customers and overall compliance with applicable CLIA, CAP and NYS regulations and policies.  Brings compliance issues to the attention of management and works with them to addresses the issues promptly.  Actively participates in internal and external Management and Quality meetings, including inspections and audits.  In addition, maintains CQ requirements for NYS.

Prepares and oversees detailed method validation/verification plans and summary reports as well as standard operating procedures (SOPs), and job aids.  Also, is responsible for supervising the work of molecular technologists, fellows and medical students in these processes including training and teaching staff, colleagues and other health care professionals.

Responsible for interpreting the results of routine and esoteric molecular assays, includes writing supplements to laboratory interpretive reports on molecular assays.  Also provides consultation to clinicians on appropriate molecular test utilization.

Identifies and implements a commercially available bioinformatics pipeline for sequencing data, including variant annotation.  Works closely with the IT department in maintaining and continuously improving the clinical database of genomic variants (in house and publicly / privately available).

Continually updating of professional skills and knowledge by survey of current scientific literature, attending training courses and conferences and participating in publication and research activities within Vitalant.

Develops and monitors clinical trials and product evaluations.  Publishes results in peer-reviewed journals as appropriate.

Monitors operating budget for assigned area.  Applies grants to fund research and develop projects as clinical responsibilities permit.

Performs all other duties, at the discretion of management, as assigned.

 

REQUIREMENTS:

Knowledge/Education

Ph.D. in molecular biology, or molecular genetics or related field required.

ABMGG certification or Active Candidate Status in Clinical Molecular Genetics required.

Two years of clinical laboratory experience preferred.

Additional laboratory skills such as flow cytometry preferred.

Knowledge in clinical laboratory operations and management preferred.

Working knowledge of method validation and statistical quality control preferred.

Licenses/Certifications

Appropriate board certification (e.g. American Board of Molecular Genetics and Genomics).

Experience

Five years of experience in molecular technology required.  To include: proficient knowledge of next-generation sequencing technologies.

Additional laboratory skills such as flow cytometry preferred.

Previous experience in writing reports for scientific publication in peer reviewed journals preferred.

Skills/Abilities

Must have broad understanding of Molecular Genetics and the latest research developments as they pertain to inherited disorders of hemostasis and thrombosis and related tools and techniques.

Good supervisory skills with the ability to effectively utilize and develop personnel to execute job tasks.

Must possess exceptional oral and written communication, interpersonal and presentation skills.

Must have strong problem-solving skills and ability to work in the group to analyze complex data.

Strong computer skills to include statistical analysis.

Ability to apply understanding of scientific theory to the structure and execution of research experiments.

Ability to coordinate scientific information with business application.

Must possess the skills and abilities to successfully perform all assigned duties and responsibilities. 

Must be able to maintain confidentiality.