Lead, Development & Validation, LM Pathology & Laboratory Medicine

Job Summary:

In accordance with the Mission, Vision and Values, and strategic directions of PHSA, safety, including both patient and employee safety, is a priority and a responsibility shared by everyone at PHSA. As such, the requirement to continuously improve quality and safety is inherent in all aspects of this position.
The Lead, Development & Validation is an applied scientist with experience in method development and validation of new methodologies and instrumentation who works as part of the Department of Pathology and Laboratory Medicine at BC Children’s and BC Women’s Hospitals that provides complex clinical laboratory testing for providers, patients and families across British Columbia. The Lead, Development & Validation has matrix reporting to the Medical Division Heads for functional/technical direction and administratively to the Operations Director or designate and works work with colleagues across Laboratory Divisions to advance clinical and academic activities. The position provides leadership in the technical development and validation of new and cutting edge assays, the improvement or troubleshooting of existing assays, statistical analysis investigating method performance, validation or troubleshooting of instrumentation, and collaborates on laboratory method development priorities. Creates reports for management decision-making on new methodologies, technology and instrumentation with potential impact to quality, budget, and staff including automation; researches, designs and carries out scientific studies; and problem solves complex laboratory analytical challenges and makes recommendations. The Lead designs and leads testing validation activities; provides leadership on quality assurance on all testing, executes designs and approved plans; consults and works closely with laboratory physicians and PhD scientists, including Medical Division Heads; keeps operational leadership informed of progress; and provides technical direction to Technical Coordinators (medical lab technologists) regarding validation activities.

Duties/Accountabilities:

• Researches, evaluates and suggests improvements for laboratory procedures, equipment and instrumentation relating to sample preparation and analysis with the objectives of (1) improved quality of testing such as enhanced analytical performance, (2) increasing throughput for large volume testing assays, (3) decreased per sample cost, and (4) improved turnaround time.
• Works collaboratively with medical staff and operations leadership to determine priorities for method development in the laboratory. Collaborates with clinical and technical staff to create or improve Standard Operating Procedures that the rest of the laboratory has to follow.
• Uses exceptional project management skills to lead the validation and implementation of new clinical assays, ensuring the validation and related documentation conforms to accreditation requirements under the direction of the Divisional medical leaders. Keeps accurate records of data collected for assay evaluation and validation and uses statistical skills to prepare performance data for review and approval.
• Establishes procedures to monitor the ongoing performance of clinical assays including design and use of statistical algorithms to indicate performance changes requiring intervention.
• Trains technologists in new methodologies and troubleshooting existing laboratory assays when required. Provides technical work direction to Technical Coordinators (medical lab technologists) relating to validation activities.
• Makes recommendations and prepares reports for management decision-making including those that impact budgets, staff, and quality. Performs and summarizes technology assessment activities to enable a thorough comparison of methodologies and instrumentation available on the market.
• Routinely engages in the Department community of medical practice. Keeps up-to-date regarding technological advancement with evolving analytical change developments through literature review, contact with peers at other organizations, professional associations and attendance at seminars, workshop and education programs. Communicates information and makes recommendations to the Laboratory Division Heads.
• Assists medical and technical staff in accreditation processes and the maintenance of a quality system in the laboratory. Participates in quality improvement initiatives, meeting and committees, represents leadership, and provides technical expertise.

Qualifications:

A level of education, training, and experience equivalent to a PhD in biochemistry, analytical chemistry, experimental pathology or equivalent with extensive hands-on experience in one or more medical laboratory science plus three to five (3-5) year’s in an analytical laboratory environment in addition to hands on assay development and method validation. Exceptional Master of Science candidates with five to seven (5-7) relevant work experience may be considered. Previous experience in a clinical or otherwise regulated analytical environment (biotechnology, pharmaceutical, contract research, etc.) is preferred.
Demonstrated technical expertise in analytical principles and biomedical sciences. Strong statistical skills and ability to interact with a variety of software applications. Demonstrated knowledge of foundational quality assurance principles. Strong analytical track record. Effective project manager; demonstrated ability to effectively manage multiple complex projects.
Detail-oriented, organized, and dedicated scientist. Proven interpersonal skills to foster strong working relationships and collaborations amongst members in the Department as well as throughout the Hospital and PHSA. Outstanding communication skills, both verbally and in writing. Demonstrated capacity to communicate in a genuine, thoughtful, and respectful manner. Effective collaboration skills. Be open to taking direction and shifting priorities as required. Demonstrated ability to lead by example and provide technical direction.