Assoc Scientist Bioscience

• 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.

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

All your information will be kept confidential according to EEO guidelines.