Technical
Laboratory
Supervisor (US)

 

Your job in a nutshell

As Technical Laboratory Supervisor you are accountable for the accuracy and reliability of all laboratory services provided by SkylineDx USA, Inc. Responsible for day to day operational management and oversight of all laboratory operations, personnel, and for monitoring the production of medical diagnostic testing in the CAP certified CLIA lab performed by assigned clinical lab personnel. You will work closely with internal and external contacts including suppliers, physicians, and other healthcare providers regarding clinical laboratory testing, operations, and development of new tests.  Supervising routine and the specialties Flow cytometry and complex molecular testing. Including analyzing and interpreting results and developing, validating and implementing new assays. You will have regular (weekly) meetings with the headquarters in the Netherlands.

Together we ensure the validation and implementation of clinically relevant scientific discoveries into reliable medical diagnostic assays for diagnosis, prognosis and drug effectiveness prediction that will ultimately contribute to improved patient care. 

 

You have

  • Bachelor’s Degree from an approved college or university and be a graduate of an accredited school of Medical technology, or equivalent. Prior to 2/28/92, have qualified at the Medical Technologist level by achieving a satisfactory grade on an HHS examination.

  • All CLIA requirements for Technical supervisor. A registered or registry eligible in accordance with an approved certifying agency (ASCP, NCA, AMT or equivalent). California Clinical Laboratory Scientist-Generalist Licensed.4-6 years as medical technologist experienced in high complexity testing including flow cytometry.

  • Familiarity with working in a QMS in a regulated environment (required).

  • Experience in developing QA-related forms in an eQMS, in Excel or Word (required)

  • Experience with an eQMS.

  • Knowledge of software development (pre)

  • Familiarity with deviation and change control management.

  • Knowledge of ISO 13485, ISO 27001, ISO 15189, FDA 21 CRF part 820 and/or other quality management standards and regulations that are relevant to the Life Science area.

  • Knowledge of EU directive 98/79/EC and/or EU regulation 2017/746 on CE marking of in vitro Diagnostic Medical Devices (IVD) and/or FDA 510(k) clearance or pre-market approval (pre).

  • Proven and adequate skills in writing procedures and reports (required).

  • an excellent command in written and spoken English (pre).

  • a hands-on mentality and result oriented attitude.

  • an entrepreneurial mind-set and are able to work in an environment with high quality standards.

  • the ability to motivate the team and manage both internal and external collaborations.

  • affinity with our corporate quotes (must).

 

We offer

  • a full-time (days-, weekends and holidays rotating shifts) position, a market competitive salary and market competitive secondary conditions of employment.

  • opportunities for personal growth.

  • the best of two worlds: a career in life sciences at an innovative biotech company with the emphasis on clinical diagnostics in close collaboration with an academic environment.

  • the ability to serve society with science based solutions.

 

At SkylineDx

we live to make a difference. It is our mission to improve a patient’s quality of life by enabling them to benefit from personal insights at the genomic level of their disease. That means we are continuously innovating the world of gene signature-based diagnostic testing. That also means we have a unique blend of characteristics. We have our soft side. Our culture is oftentimes described as familial, warm, loyal and highly engaged. We have our rational side where exact sciences are driving our mission. And when needed our passionate side surfaces to clear the way so we can serve society with science based solutions.

 

Our quotes

#serviceisjoy

#valueformoney

#playtogethertowin

#amazingthingshappen

#cogitoergosum

#itsyourparty

 

Do apply!

Send your resume and motivation letter to Deborah Wigmans (HR) at info@skylinedx.com. If you have questions or want more information, don’t hesitate to contact us. You’ll find the contact details on our website. We will make sure it lands on the right desk!