Bioanalytical Development Group in Preclinical Sciences is seeking a highly talented and motivated Senior Associate or Associate Scientist with a strong immunology background and extensive experience in bioanalytical method development. Successful candidate will contribute to the development of pharmacokinetic (PK), anti-drug antibody (ADA) and biomarker assays to support activities spanning from early discovery to late phase clinical trials. The individual is expected to develop and qualify ligand based assays in multiple matrices using state-of-the art platforms and techniques and be able to work with cross-functional teams for biotherapeutic products at various stages of research and development. The candidate is expected to function with minimal supervision. This position is located at Xencor’s headquarters in Monrovia, CA.
Job Duties Include:
• Hands-on development, qualification, and conduct of bioanalytical assays for large molecule therapeutics in biological matrices, including PK, ADA, ADC, Nab, biomarkers to support pre-clinical and clinical studies.
• Support in-house bioanalysis for early discovery projects as needed, including performance of a qualified assay, SoftMax Pro 7 analysis, and WinNonLin PK parameter analysis.
• Develop methods by applying and interpreting scientific theories, concepts, techniques, and regulatory requirements in bioanalytical studies.
• Implement design of experiments (DOE) and other systematic and statistical approaches to method development.
• Transfer developed assays to CRO’s, including travel and analyst training.
• Analyze samples for research studies,
• Author and review technical study reports and regulatory submissions
• Maintain current knowledge of the field and area(s) of scientific expertise and development
• Minimum of a Bachelor’s degree in Biochemistry, Chemistry or Biology required. An advanced degree is preferred.
• 10+ years of related biotech or CRO industry experience is required.
• The candidate must have proven proficiency in immunoassay development and be capable of working on multiple projects simultaneously.
• Prior experience working in a regulated GLP compliant environment is preferred.
• Experience in one or more immunoassay techniques (ligand binding assay: ELISA, MSD, Biacore, and/or bead arrays applicable to Pharmacokinetic, Immunogenicity, ± biomarker studies).
• High competence in common software and data analysis packages (eg, Microsoft Office Suite, SoftMax Pro, GraphPad Prism, JMP or MiniTab, WinNonLin).
• Strong knowledge of FDA and ICH guidance documents for critical reagents, bioanalytical method development, validation, and trending is essential
• Strong communication skills and the ability to work with staff in other locations effectively.
Xencor Inc. is an innovative biotechnology company located in the Los Angeles area (near Pasadena) and in San Diego. We have a fast-expanding clinical pipeline of promising therapeutic candidates, which creates an exciting opportunity to join our team. We use our pioneering XmAb® technology to develop better biotherapeutics – antibodies that target new biological mechanisms and are more potent, safer and longer lasting – to improve patient outcomes and quality of life. In addition to generating a pipeline of novel drug candidates, with eleven in clinical testing by Xencor or our partners, our XmAb® technology has been validated through our collaborative agreements with leading biopharmaceutical companies including Novartis, Amgen, Morphosys, Merck, CSL, Janssen (J&J), Alexion and Boehringer Ingelheim.
Our employees are the most important factor in our success and we have assembled a highly talented group from diverse backgrounds and disciplines to execute our business plan and shape our future. Xencor employees value new ideas and flexibility and demand from each other scientific rigor, a passion for innovation, and a willingness to take risks.