Assay Development Scientist-Onsite

Under supervision of the Director of the Medical Microbiology, leads assignments related to development of new laboratory developed tests (LDT), evaluation of new laboratory diagnostic methods, improvement of existing testing platforms, validation of software, maintenance of biorepository, and training of clinical laboratory staff. Provides technical support to microbiology laboratory personnel and investigative support to clinical trials and other clinical research projects at City of Hope. Presents scientific data at the scientific conferences.

Primary responsibility is validating the laboratory developed tests as applicable to clinical laboratory practices.

• Research literature for improvements in infectious disease diagnostic technologies.

• Determines efficacy of new laboratory instruments.

• Writes SOPs Validations for the above.

• Assists in the training of clinical laboratory personnel in the newly established technologies and instrumentation.

• Develops preventive maintenance protocols.

Ensures that a procedure manual of all methodologies and techniques performed is maintained, updated and modified as new methods are introduced.

Functions as a resource to department staff; recommends solutions to personnel or technical problems.

Responsible party for technical transfer of new development to clinical use

Responsible for establishing preventative maintenance program for new technology

Assists Laboratory Supervisor to develop Quality Control and Quality Improvement Programs.

Assists as needed to prepare all materials pertinent to self-guided and onsite inspections (CAP, JCAHO, and other regulatory agencies

As a successful candidate, you will:

Your qualifications should include:

· Ph.D. in Biological Sciences. 3 additional years of experience as a CLS plus the minimum experience requirement may substitute for minimum education.

· PhD with 1 year laboratory experience in microbiology or CLS with 6 months CLS laboratory experience in microbiology. Relevant laboratory experience required.

· Medical microbiology courses Maintains up-to-date knowledge of laboratory regulations

· Non-PhD must have MT (Medical Technologist) or CLS (Clinical Laboratory Scientist) License

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