© 2019 Helomics Corp. All rights reserved.

  • White Twitter Icon
  • Facebook - White Circle
  • White LinkedIn Icon

Director, Laboratory Operations

DEPARTMENT: Laboratory Operations

The Opportunity:

Helomics is an Integrated Clinical Contract Research Organization located in the Lawrenceville neighborhood of Pittsburgh, PA. Helomics mission is to improve the standard of care for cancer patients through innovative research and development partnerships with pharmaceutical, diagnostic, biotechnology, and academic organizations, leading to better and more personalized treatments and diagnostic technologies for human disease. Helomics’ CLIA-certified lab provides clinical testing that assists oncologists and surgeons in individualizing patient treatment decisions. 

Duties & Responsibilities: (Not limited to…)

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. 

 

Other duties and responsibilities as may be assigned.

 

Qualifications:

 

  • Education:

    • Bachelor of Science degree with a major in a biological or related science AND

      • 8+ years of experience in a CLIA-certified laboratory

OR

  • Master of Science degree with a major in a biological or related science AND

    • 6+ years of experience in a CLIA-certified laboratory

OR

  • Ph.D. with a focus in biological or related science AND

    • 2+ years of experience in a CLIA-certified laboratory

 

  • Experience:

    • 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

 

  • Required Skills:

 

Soft Skills

  • Leader – demonstrated leadership skills

    • Lead direct reports (technical team) in the execution of the commercial test(s)

    • Lead cross-functional activities and departments

  • Team Builder

  • 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 – Documentation

 

Technical 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

If you meet the requirements and are seeking a dynamic, challenging atmosphere, with the opportunity to make a difference to help oncologists and their patients, email your resume to Resumes@Helomics.com with the words “Director, Laboratory Operations” in the subject of the email.