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Safety Physician Senior Analyst: Immunoassay Reagent Generation and Characterization

Your Responsibilities: Seeking a highly motivated, flexible and experienced scientist with demonstrated expertise in reagent characterization. The successful candidate will have experience in protein conjugation, purification and characterization in the <1mg to 200 mg range.  This individual will be responsible for generating and purifying critical reagents (e.g. antigens, peptides, drug, anti-idiotypic polyclonal antibodies and antibody fragments) with and without conjugations (e.g. biotin, ruthenium and fluorescent labels) to support PK, immunogenicity and biomarker method development and testing in a GxP environment. This individual will also conduct characterization studies of purified critical reagents and generate Certificates of Analyses. The successful candidate will possess a working understanding of biochemical techniques including protein HPLC, FPLC, SEC, cIEF, Biacore/Octet, and familiarity with analytical platforms including ELISA, ECLIA and mass spectrometry. The successful candidate will contribute to the reagent characterization efforts across Bioanalysis, Immunogenicity and Biomarkers in the US, and will work closely with internal (GSK) and external partners Key Responsibilities: o Responsible for the generation, purification, characterization and quality of critical assay reagents o Produce certificates of analysis (CofA) for assay reagents. o Monitor reagents life cycle and assist with reagent trouble shooting investigations. o Drive reagent generation projects (technical expertise and project management) with third party external vendors o Demonstrate strong technical writing experience (SOPs, Protocols and Reports) Improve long-term assay robustness through production of well characterized reagents o Perform analytical testing as needed o Evaluate new platforms/technologies and develop new techniques as needed. o Holds him/herself accountable for delivering high quality reagents, and be fully compliant with regulatory requirements.   o Adhere to agreed timelines o Demonstrate ability to handle multiple projects concurrently o Function well in a team and possess a good balance of creative and analytical skills o Present at internal and external meetings o May manage reagent team staff LI-GSK Why You? Basic qualifications: o PhD with 2 years of related experience in analytical sciences, life sciences or related field, MS with 5 years of related experience, or BS with 10 years of related experience o A minimum of 2 years of experience of working in the pharmaceutical or biotechnology industry o A thorough understanding of reagent generation and characterization in a regulated laboratory environment Preferred qualifications: o Ph.D. or equivalent technical skills demonstrated through research and publication experience o Multiple years of experience in protein FPLC, HPLC, SEC, cIEF and Biacore/Octet in a regulated environment WD183648
Salary Range: NA
Minimum Qualification
11 - 15 years

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