Biomarker Assay Specialist (Multiple Positions)
Location:
San Diego , California
Posted:
August 13, 2016
Reference:
1036685


About the company
A career at the company offers opportunity, ownership and impact.

All over the world, the company colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. the company, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.

Role Description
The position plays a critical role in supporting Translational Oncology strategies through scientific technical oversight and management of external and internal partners involved in the implementation of clinical trial biomarker sample analyses

Responsibilities
• Provides bio-analytical assay technical and operational expertise to Study Teams to ensure delivery of high quality clinical biomarker data.
• Prepares and reviews bioanalytical reports: contributes to regulatory submissions and responds to regulatory queries when needed.
• Key point of contact with external commercial and academic clinical laboratories, as well as internal clinical labs, with oversight responsibilities for agreements, work plans, budget and invoices, assay transfer, assay validation, sample analyses, data transfers and overall data quality.
• Provides technical support for selection, qualification and periodic audits of CRO laboratories supporting clinical trial biomarker assays.
• Coordinates with internal partners to ensure appropriate biomarker sample handling and processing steps are appropriately described in the clinical trial Laboratory Manual.
• Contributes to the ongoing development of Best Practices processes and templates.
• Maintains up-to-date knowledge of biomarker assay technologies and clinical laboratory standards, regulatory guidance and compliance

Qualifications
• Well-qualified candidates with have a Ph.D., or B.S., M.S., and additional certification in Clinical Laboratory Sciences, and significant experience in biomarker analyses and clinical laboratory testing in Oncology, Molecular Oncology, or Hematopathology.
• Minimum of five years of industry or clinical laboratory experience in biomarker assay development, assay validation and implementation within clinical trials, employing a broad range of platform technologies (e.g. RNAseq, NanoString, NGS, IHC, PCR, FISH, flow cytometry, other cell based and circulating biomarker technologies).
• Demonstrated experience with clinical laboratory regulatory and compliance requirements, and hand's on knowledge of global regulatory requirements including GLP, GCP and the clinical trial process.
• Assay problem solving and analytical skills; ability to resolve technical issues that may arise during method development, assay validation and sample analysis.
• Demonstrated ability to think strategically and creatively while contributing to multiple projects.
• Outstanding ability to work productively in a collaborative, multi-disciplinary and diverse team setting
• Highly effective verbal and written communication skills.

Other Information - Internal
Colleagues who are issued an Incident Final Warning (IFW) on or after January 1, 2016, are not eligible to post and compete for a position for a period of 12-months from the date an IFW is issued.

EEO & Employment Eligibility
the company is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. the company also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. the company is an E-Verify employer.
A little about us:
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