R&D Scientist (US)

 

Your job in a nutshell

The R&D Scientist is responsible for leading assay support services including troubleshooting and assay transfer activities and process development in support of the CLIA laboratory at SkylineDx USA. This role will work closely with a wide variety of departments including but not limited to the clinical laboratory team, research and development teams, laboratory management and quality. The following is a list of job duties for the role:

  • Train to all relevant assay SOPs related to the job function and adhere to all rules and protocols.

  • Be proficient in current clinical assays with the ability to be utilized as a subject matter expert.

  • Work with senior management to define strategy and communicate strategy progress to senior management.

  • Participate in clinical project teams. Play an integral role in the transfer and launch of products from SkylineDx BV Research and Development team for use in SkylineDx USA CAP/CLIA accredited laboratory in San Diego.

  • Assist in the preparation of validation documentation of new tests and procedures, where needed.

  • Provide training to laboratory staff on new products prior to transfer.

  • Identify problems that may adversely affect test performance or reporting of test results.

  • Review, plan, set-up, and execute protocols to support or troubleshoot current clinical assays.

  • Implement new systems in the laboratory, including automation and temperature monitoring.

  • Plan and develop process improvements to help streamline laboratory efficiency and decrease COGS.

  • Write, revise and collaborate on laboratory procedures.

  • Collaborate with key departments to define/deliver study-specific plans.

  • Provide support for other R&D, Customer Service, Sales, IT activities as required.

  • Provide ancillary support for quality audits and vendor selection as needed.

  • Comply with HIPAA requirements relevant to the role and duties assigned.

  • Fulfill other responsibilities as assigned.


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

  • a Master’s degree in, molecular biology, biological sciences or a related field (required).

  • an advanced molecular skill set consisting of RNA and DNA extraction, PCR, reverse transcription, and gel electrophoresis. NGS experience is preferred.

  • 2-3 years of experience in clinical research, with good understanding of the collection, handling and processing of tissue specimens, blood and other clinical samples in a biotech/pharmaceutical industry or academic.

  • experience in scaling a clinical laboratory (preferred).

  • familiarity with working in a QMS in a regulated environment (required)

  • strong analytical skills and creative approach to problem solving.

  • 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 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 Stephani Hernandez at s.hernandez@skylinedx.com. If you have questions or want more information, don’t hesitate to contact us. You’ll find the contact details here on our website. We will make sure it lands on the right desk!