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Cepheid administers its personnel policies and conducts its employment practices in a manner that treats each employee and applicant for employment on the basis of merit and experience, without regard to race, creed, color, national origin, sex (including pregnancy, childbirth, or related medical conditions), age, physical or mental disability, marital status, sexual orientation, citizenship status, ancestry, religion, gender identity, or any other protected characteristic as established by law.
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As a member of the Cepheid R&D organization, the successful Senior Scientist candidate will develop molecular diagnostic products which incorporate real-time amplification and detection of nucleic acids for use in the Cepheid GeneXpert instrument system. Research and development efforts will be conducted in compliance with safety and international regulatory requirements.
Optimize real time PCR and RT-PCR assays for the GeneXpert platform based on design input requirements.
Help devise strategies for development of diagnostic tests for infectious disease products.
Help develop and write verification and validation SOPs and technical reports.
Maintain detailed experimental records.
Apply analytical problem solving skills to reagent and system integration issues to identify critical performance factors.
Creation of specifications and analytical tests for the qualification and release of products.
Present data at technical meetings and reviews.
Provide input to the project schedule as required.
Required Knowledge - Skills - and Abilities:
Master's degree in Molecular Biology, Cancer Biology, Virology or Biochemistry, or related Life Science discipline.
A minimum of 6 years relevant professional experience in assay design, reagent optimization and design control.
Should have sound knowledge of laboratory safety and biosafety practices required.
Strong proficiency with product development, expert knowledge of scientific principles and concepts, and a high level of scientific creativity and technical proficiency.
Strong technical skills must include nucleic acid amplification and real-time detection, DNA polymerase functional performance and stability determination, and nucleic acid isolation/purification.
A sound knowledge of statistical design of experiments is highly desirable.
Strong competency in analysis of complex experimental data, and presentation of laboratory results a must.
Excellent computer, written and oral communication skills, and proven interpersonal skills and teamwork are required.
- Must possess skills/knowledge in handling clinical samples and be able to work in a BSL-2 environment.
- Knowledge of cGMP, Design Control and the FDA approval process would be a plus.
- PhD degree is a plus.