Medical Laboratory Director
5100 Campus Drive, Suite 120
Plymouth Meeting, , PA 19462
This is an exciting time at ANGLE and at our facility in the Greater Philadelphia area, we are looking for a Medical Laboratory Director. The Medical Laboratory Director, in accordance with the Clinical Laboratory Improvements Amendments Act (CLIA) Regulations, oversees all aspects of patient management testing and reporting.
Essential Duties and Responsibilities:
- Together with the Head of Clinical Laboratories, assess, implement, and monitor the clinical laboratory quality management system. Ensure compliance with all applicable regulations.
- Provide input on test selection, validation, and implementation.
- Review and approve all CLIA regulated SOPs, at a minimum on an annual basis.
- Together with the Head of Clinical Laboratories, ensure that facilities, personnel, and services meet CLIA requirements when applicable.
- Ensure that consultation is available to the laboratory’s clients on matters relating to the quality of the test results reported and their interpretation concerning specific patient conditions.
- Perform such other duties and responsibilities that are consistent with the role of a Medical Laboratory Director or as may be assigned from time to time.
- Strong scientific/technical aptitude
- Maintains an infallible degree of discretion, integrity, and confidentiality
- Absolute integrity and respect for patient confidentiality when dealing with clinical samples
- Committed to continuous improvement of processes and/or products
- A driver of commitment to quality throughout the company
- Strong commitment to continuous improvement of processes, employee capabilities, and the production of high-quality results
- Strong verbal and written communication skills
- Ability to multitask and prioritize to meet deadlines
- Ability to work both independently with minimal supervision as well as in a team environment
- An eye for detail and commitment to high quality data
- Continuous learner with a keen appetite for cross-disciplinary work
- A flexible, can-do approach to the requirements of the job
- Entrepreneurial thinking and work ethic
Required Experience, Education and Knowledge:
- M.D., preferably with Anatomic and Clinical Pathology Board Certifications and any additional licensing requirements necessary to perform the role of Medical Laboratory Director in the State of Pennsylvania.
- Experience in the medical management of laboratory operations, in addition to the review and interpretation of test results
- Working knowledge of appropriate regulatory requirements (e.g. cGLP, ISO, CLIA, OSHA, HAZCOM)
How to Apply
How to Apply
Please reference the position: “Medical Laboratory Director”.
All applications will be kept confidential. We thank all candidates for their interest, but only candidates selected for an interview will be contacted.
At ANGLE North America Inc. we are committed to maintaining and developing a qualified workforce that reflects the diverse population it serves, and we welcome applications from all qualified individuals. We value diversity and we do not discriminate on the basis of race, religion, color, sex, age, non-disqualifying physical or mental disability, national origin, sexual orientation, gender identity or expression, or any other basis covered by local law. We are also committed to preventing and removing barriers to employment for people with disabilities, and we invite you to inform us should you have any accessibility or accommodation needs.
About Our Organization
ANGLE is a world-leading liquid biopsy company with offices in Guildford (UK), Toronto (Canada) and the Greater Philadelphia area (US). ANGLE’s proven patent protected liquid biopsy platform products have the potential to be used in cancer diagnostics to enable early, accurate identification of an individual’s condition for the prevention, treatment, and monitoring of disease.
With 1 in 2 UK people being diagnosed with cancer in their lifetime*, ANGLE’s liquid biopsy technologies have the potential to help clinicians select the most appropriate drugs and therapies for an individual patient. As such, our technologies support the development of Precision Medicine.
In 2021 we opened GCLP compliant clinical laboratories in Guildford (UK) and the Greater Philadelphia area (US) to provide “pharma services” for cancer drug trials and, once the labs are accredited, laboratory developed tests (LDTs) for patient management. The pharma services business offers dynamic analysis of patient condition before, during and after the patient receives the drug, assessing both CTCs and CTC clusters recovered from a simple blood test.
We are also pursuing an FDA product clearance for the Parsortix system and have submitted a full De Novo submission, which is currently in substantive review with FDA.
*Source: Cancer - NHS (www.nhs.uk)