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Biomarker Assay Development Scientist

Research Scientist | Houston, TX | Contract

Job Description
Biomarker Assay Development Scientist
Work Location: Houston, TX

Job Summary/Description
Advancing novel biomarker discoveries from initial observation to the clinic is a daunting process and requires a complex set of experience outside of basic laboratory skills. This team at MD Anderson is focused on moving biomarker assays for early detection of cancer to the clinic and needs an assay development consultant to lead efforts to validate current assays in the clinical laboratory and partner with technology transfer to facilitate commercialization of these assays. This individual will have both academic and industry experience with clinical assay development and knowledgeable of FDA requirements for clearance.

Job Duties/Responsibilities/Functions (including but not limited to)
• Expertise in the development of assays for clinical laboratory use either as a laboratory developed test or as an FDA regulated medical device
• Experience in the development of clinical assay controls and reference standards that satisfy clinical laboratory regulatory requirements (i.e. CAP, CLIA)
• Ability to lead and interact with a diverse group of scientists, technology transfer and external partners/investors
• Extensive experience with basic molecular/cell biology techniques including cell culture, transfection, next generation sequencing, ELISA, antibody optimization, etc
• Data analysis/bioinformatics expertise with complex data sets from next generation sequencing, as well as, algorithm optimization/machine learning as applied to multiparameter datasets
• Ability to independently design, interpret, present and report scientific findings clearly to both internal and external audiences
• Experience in maintaining a laboratory quality control program, assuring compliance with policies and standards of regulatory agencies
• Ability to develop web-based data analysis portals in Django/Python, as well as, development of analysis/modeling in the R language
• Performs other duties as assigned.

Minimum Qualifications
• Required: PhD in a biomedical science discipline
• Required: Certification consistent with clinical laboratory standards as a technologist or specialist (ex. MB(ASCP))
• Required: 10+ years in clinical assay development either in a CLIA/CAP certified laboratory or in a company developing assays for FDA clearance/certification.
• Required: 5+ years’ experience in bioinformatics/data analytics and knowledge of Python, R and Django.
• Preferred: Extensive project management experience leading diverse teams of scientists and business/legal partners.

About InGenesis
InGenesis is dedicated to placing people in positions that preserve life, improve lives and inspire others. This does not happen without passionate people, skilled colleagues who are motivated to create innovative solutions and deliver superior service to our clients. Founded in 1998, InGenesis manages thousands of employees, including pioneering healthcare, science, technology and pharma professionals. The workforce solutions company includes almost half of the Fortune 500 in its nearly 300 clients. It is recognized as one of the largest healthcare staffing firms, and InGenesis is the largest minority/women owned healthcare staffing firm in North America.

EEOC Statement
We support a diverse workforce and is an Equal Opportunity Employer who does not discriminate against employees and applicants for employment on the basis of race, gender, color, religion, national origin, age, sexual orientation, gender identity, genetic information, disability, veteran status, or other classification protected by law.