Associate Scientist I/II
Company: Katalyst Healthcares & Life Sciences
Location: Mountain View
Posted on: September 16, 2020
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Job Description:
Katalyst Healthcares & Life Sciences is hiring entry level
candidates for several positions for contract research in Clinical
trials of drugs, biologics and medical devices. We have a few immediate job opportunities available in Drug
Safety and Pharmacovigilance and Clinical Research field. We work
with University hospitals, pharmaceutical companies and recruiting
partners. Job Description Description: The Global PK-PD & Bioanalysis Associate Scientist I/II provides
analytical support for biotherapeutic projects. The bioanlytical
functions will include (but are not limited to) the development,
validation, and conduct of immunoassays for the determination of
drug in biological matrices, assessment of drug immunogenicity, and
development of relevant biomarker assays under minimal supervision.
Familiarity with GLP regulations is a plus. Major Responsibilities Establish, develop, and qualify/validate qualitative and
quantitative immunoassays for drug substances, biomarkers and
anti-drug antibodies in biological matrices such as serum and/or
plasma. To be creative and have analytical capabilities to troubleshoot
challenging immunoassays Write qualification protocols and reports and Standard Operating
Procedures. Conduct sample analysis and data review in support of
pharmacology, toxicology and clinical studies in a GLP-compliant
laboratory. Coordinate assay transfer, establish sample analysis, initiate
validation studies with contract laboratories. Compile assay qualification and bioanalytical reports. Requirements/Qualifications: Education: Associate Scientist
I: Bachelor's or Master's Degree in biological science or related
field Minimum 5-8 years relevant experience (2-5 years with Master's
Degree) Associate Scientist II: Bachelor's or Master's Degree in biological science or related
field Minimum 8-10 years relevant experience (5-8 years with Master's
Degree) Experience: Strong background in immunochemical assay development. Knowledge of assay validation guidelines and GLP regulations is
a plus. Experience working with antibodies and biological matrices such
as whole blood, serum and plasma is a plus. Familiarity with MSD and colorimetric or luminescent plate
readers. Proficiency with spreadsheet, word processing, and graphical
computer programs (MS EXCEL, MS WORD, Graphpad Prism, for example)
required. Excellent skills in organization, communication, documentation
and technical writing are required Additional Information All your information will be kept
confidential according to EEO guidelines. Other jobs at Katalyst Healthcares & Life Sciences
Keywords: Katalyst Healthcares & Life Sciences, Mountain View , Associate Scientist I/II, Other , Mountain View, California
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