Predicine is a molecular insight company developing genomic profiling tests and robust algorithms for cancer diagnostics and monitoring. Our biology-oriented approach to analyzing genomics is advancing the understanding of tumor mutational landscape. We are applying our expertise in genomic profiling to identify elusive cancer-related genetic changes and new biomarker targets across many cancer types. Our advanced cancer genome analysis helps researchers and biopharmaceutical partners accelerate new precision medicine development. At Predicine, we are passionate about our people, technology, and creating a lasting impact in cancer research. If you enjoy challenges, collaborating with others to solve complex problems, and the chance to see your work impact the millions of lives touched by cancer, this is the place to be!
CLIA Lab Manager – (Onsite Hayward CA)
In this position you be responsible for the daily operations of the Clinical NGS laboratory including but not limited to :
- Supervising of the staff, troubleshooting and resolving technical and non-technical high complexity problems.
- Perform laboratory tests, procedures, and analyses according to the laboratory’s standard operating procedures as needed.
- Review, interpret and report patient results in LIMS as needed.
- Lead the introduction of clinical assay improvements, new assay configurations and validation.
- Perform, review and document laboratory quality control procedures as needed. Document all corrective
Training and Operations
- Identifying personnel training needs and ensuring staff / team maintain their competency.
- Running NGS clinical laboratory daily operations
- Ensuring that patient test results are not reported until all corrective actions have been taken and the test system is functioning properly
- Work with cross functional teams, including but not limited to CD, BD, R&D, and IVD for Assay Validation, CLIA/IVD/RUO, QA and Dry Lab
- Participate in the inspection preparation activities as needed with Pharma and other regulatory bodies.
- Participate in Quality Assurance activities(w/ QA), and maintain stringent standards for quality, identifying any issues which might adversely impact the quality of test results and/or employee safety, and communicating these to the laboratory directors, quality manager and Safety Officer as necessary for resolution.
- Ensure laboratory staff conducts highly complex diagnostic procedures according to Standard Operating Procedures, including specimen processing, performing test procedures, data analysis and reporting results
Qualifications/ Education/ Experience:
- Current California Clinical Laboratory Scientist license. (CA) Required
- Bachelor’s Degree(Required)
- Minimum of eight (8) years laboratory experience with at least four (4) years of direct supervisory experience in the clinical or anatomical pathology laboratory.
Our Opportunity: Candidate Location: Onsite Hayward, CAEstimate Of Salary Range: $150,000 – $200,000 BaseAll full-time roles in the US come with a robust benefits package which includes healthcare, dental, and vision insurance. Additional benefits include PTO, paid holidays and 401(k) retirement plan. The posted salary range is the estimated base salary range for this position. Should the level or location of the role change during the hiring process, the applicable salary range may be updated accordingly.
Compensation decisions are dependent on several factors including, but not limited to, an individual’s qualifications, location where the role is to be performed, internal equity, and alignment with market data. We are proud to be an Equal Opportunity Employer. We are committed to ensuring a diverse and inclusive workplace environment, and welcome people of different backgrounds, experiences, abilities, and perspectives. Inclusive collaboration benefits our employees, our community, and our patients, and is critical to our mission of changing the management of disease worldwide.All qualified applicants are encouraged to apply, and will be considered without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, age, veteran status, disability or any other legally protected status.
We also consider qualified applicants regardless of criminal histories, consistent with applicable laws. All your information will be kept confidential according to EEO guidelines. We require all Predicine employee's to be fully vaccinated and provide proof of vaccination on their first day of work. All job offers are contingent upon successful completion of background verification. Applicants must be legally authorized to work in the USA. We are not accepting third party resumes or agency resumes
150000.00 To 200000.00 (USD) Annually