Scientist I/II - Clinical Immunology and Bioanalysis

Location: South San Francisco, CA

Description: 

MedImmune is seeking Scientist I/II to become a part of a bioanalytical science group supporting toxicology, PK/PD and clinical studies. The primary function of the person will be the development and validation/qualification of relevant cell-based and immunoassays for biomarker measurement and the detection of anti-drug antibodies in biological matrices, such as whole blood, sputum, serum and/or plasma. The candidate will utilize multiple technology platforms, including ELISA, MSD, Luminex, fluorescence and luminescent plate readers, fluorescent microscopy and FACS. The candidate will be working in GLP/GCP environment, prepare Standard Operating Procedures, validation protocols, bioanalytical reports and support regulatory submissions. She/he will manage CRO for method transfer/validation, sample analysis and report generation. The candidate must demonstrate technical proficiency, critical thinking, teamwork and creativity in problem solving and implementation of challenging or innovative assays.

Position Summary:                               

            Major Duties and Responsibilities:

• Develop and validate immunoassays and/or cell-based assays for anti-drug antibodies, including neutralizing anti-drug antibodies in serum and/or plasma
• Develop immunochemical and cell-based assays for measurement of potential pharmacodynamic markers in biological matrices such as whole blood, serum and/or plasma
• Utilize multiple technology platforms including ELISA, MSD, Luminex, fluorescent or luminescent plate readers, FACS and fluorescent microscopy
• Lead bioanalytical sample analysis and data review in support of pharmacology, toxicology and clinical studies in a GLP-compliant laboratory 
• Prepare Standard Operating Procedures, validation protocols and bioanalytical reports
• Coordinate assay transfer and establish sample analysis, validation studies and related contracts with CRO
• Review literature in support of pharmacodynamic marker identification and utilize creative and analytical capabilities to troubleshoot and implement challenging or innovative assays

 Qualifications:

• Scientist I
• PhD in biological sciences or related field with some experience preferred
• Bachelor’s or Master’s Degree in biological science or related field with minimum 10+ years relevant experience (8+ years with Master’s Degree)

• Scientist II:   
• PhD in biological sciences or related field with 3+ years of experience
• Bachelor’s or Master’s Degree in biological science or related field with minimum 13+ years relevant experience (10+ years with Master’s Degree)

Experience: 

• Strong background in immunochemical and cell-based assays, including experience with ELISA, MSD, cell culture techniques, and general knowledge of antibodies
• Experience with Luminex, Flow cytometry and Fluorescent Microscopy is a plus
• Experience working with biological matrices such as whole blood, serum and plasma
• Knowledge of assay validation guidelines and GLP regulations is a plus
• Proficiency with spreadsheet, word processing, and graphical computer programs (MS EXCEL, MS WORD, Graphpad Prism, for example)
• Excellent organizational skills and ability to multi-task
• Ability to work in a team environment
• Strong documentation and technical writing skills
• Attention to details, critical thinking and good trouble-shooting skills

Supervision:  The Scientist I/II is expected to perform duties with minimal supervision. The appropriate candidate should have the ability to carry out complex projects and multi-task.