| Job Description | This position can be filled at either the Scientist II level or the Senior Scientist level.
The Clinical Pharmacology & DMPK Department is seeking a highly motivated individual with strong immunology background and extensive experience in bioanalytical method development to join the bioanalytical group as a Senior Scientist or Scientist II. The candidate will function as the bioanalytical leader in cross-functional teams for biotherapeutic products at various stages of research and development. The candidate will be responsible for all aspects of bioanalysis-related support, including design and execution of bioanalytical strategies for biomarker assessments in support of non-clinical and clinical studies, as well as contribution to study designs and regulatory submissions. The candidate is expected to function with minimal supervision and will report to the Director of Bioanalycal Science & Clinical Testing.
Major Duties and Responsibilities:
Represent the bioanalytical function on cross-functional project teams for the discovery and development of biotherapeutics
Design bioanalytical strategies for biomarkers to demonstrate proof-of-mechanism and to support dose selection in support of non-clinical and clinical studies
Implement bioanalytical strategies by hands-on development, validation, and conduct of bioanalytical methods, including Nab, biomarkers, clinical flow panels;
Prepare bioanalytical subreports for outsourced safety and PK/PD studies; review and finalize study reports
Review and report bioanalytical results for clinical studies
Comply with GLP regulations for GLP-compliance studies
Managing CROs for method transfer, validation, sample analysis monitoring and report generation
Contribute to non-clinical and clinical study design, data generation and reporting, regulatory document preparation, regulatory interaction and submission
Manage laboratory staff and/or data analysts, where applicable
Coordinate timelines and activities in collaboration with project management
Establish new bioanalytical capabilities and introduce new assay technologies for evaluation
Demonstrate leadership in bioanalytical field by presenting at external scientific conferences and publishing in peer-reviewed journals.
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Position Requirements This position can be filled at either the Scientist II level of the Senior Scientist level.
For senior scientist we require a PhD in Immunology or related biological sciences with a minimum of 7 years of relevant industry experience.
For the scientist II we require a PhD in Immunology or related biological sciences with a minimum of 3 years of relevant industry experience.
In addition, for both positions we require the following:
Strong Immunology background
Track record for publications in peer reviewed journals
Knowledge and prior experience of drug development, especially for immuno-therapeutics development
Extensive experience in bioanalytical method development and validation
Expertise in flow cytometry and other bioanalytical technologies, such as cell-based assay, multiplex analysis and immunoassay
Prior experience with clinical flow cytometry desired
GLP knowledge and experience preferred
Excellent interpersonal, organization and communication skills;
Experience in managing CROs
Work independently and effectively in cross-functional teams with minimal supervision
Ability to prioritize projects and time to meet project timelines in a fast-paced team environment;
Supervisory experience preferred
Req ID 8350
Position Category Research - Translational Science |
| | Company | | Medimmune, LLC | Job Code | | State or Province | | California | | |
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