The Director will have a working collaboration with the Medical Director and is responsible for planning, organizing, and directing all aspects of the clinical laboratory personnel operation. Specifically, the Director plans and implements the overall laboratory policies and procedures and ensures efficient and effective laboratory operations. This includes personnel and resource management, financial management (to include the preparation of budgets and the monitoring of spending relative to the budgets), project/change management, and compliance adherence.
The Director will foster and implement positive team culture. The ability to inspire and motivate Helomics’ highly professional and skilled laboratory personnel. Direct reports will include laboratory personnel. Additional the Director will work closely with the QA and QC Departments to promote quality at every level of laboratory operations.
Helomics’ clinical laboratories are certified with CLIA, CA, NY, FL, RI, and other regulatory agencies. The Candidate must meet the regulatory requirements for each agency. The laboratories operate under a continuous quality improvement initiative and the candidate must be familiar with data collection, analysis, and CQI methods. The successful candidate will be able to identify areas for process optimization and implement changes through Helomics’ corporate change management system. Additionally, the candidate must possess the skills required to properly navigate and successfully complete all required regulatory inspections.
This position is best suited to someone desiring to work in a proactive team environment that places strong emphasis on providing accurate and timely information to physicians.
Bachelor of Science degree with a major in a biological or related science AND
8+ years of experience in a CLIA-certified laboratory
Master of Science degree with a major in a biological or related science AND
6+ years of experience in a CLIA-certified laboratory
Ph.D. with a focus in biological or related science AND
2+ years of experience in a CLIA-certified laboratory
Previous management experience, 2+ years
Growing a team, in size and in capability
Implementing QA/QC programs
Regulatory and Corporate Compliance
Direct participation in CLIA, CA, NYSDOH, or CAP audits
Ability to serve as technical supervisor per CLIA and NYSDOH definitions
ASCP (MT or specialty category) certification (required for BS and MS candidates)
DLM (ASCP) preferred
Leader – demonstrated leadership skills
Lead direct reports (technical team) in the execution of the commercial test(s)
Lead cross-functional activities and departments
Problem solver – able to make well-informed, sound decisions
Troubleshooter – able assess day-to-day lab anomalies related to equipment, reagents, and data and act appropriately
Highly organized and detail-oriented
Accurate and thorough
Well-developed and effective communication skills
Verbal - Phone, In-Person
Written – DocumentationTechnical Skills
Maintain proficiency and competency in areas of the lab
Must be proficient with Microsoft Office Tools
Required - Outlook, Word, Excel
Preferred - Project, Visio
History of developing and meeting schedule, budget, and scope requirements
Knowledge of clinical laboratory standards and regulatory requirements including accreditation and governmental regulations
Commitment to continuous process improvement
Ability to develop policies and procedures
Perform non-conformance report (NCR) resolution
Address customer inquiries
About Helomics Corporation
Helomics over the past year has made numerous adjustments and the environment is that of a new start up company. Helomics is a Personalized Healthcare company located in Pittsburgh, PA. Helomics mission is to improve the standard of care for cancer patients (especially gynecological) through innovative research and development partnerships with pharmaceutical, diagnostic, biotechnology, and academic organizations, leading to better and more personalized treatments and diagnostic technologies cancer. Helomics’ CLIA-certified lab provides clinical testing that assists oncologists in individualizing patient treatment decisions, by providing an evidence-based roadmap for therapy.