Research Associate-Bioanalytical Development
Xencor Inc. is an innovative biotechnology company located in the Los Angeles area (near Pasadena) and in San Diego. We have a very deep drug development pipeline including five programs currently in clinical testing with three more expected to start clinical testing by 1H2019 and have an excellent opportunity for a Associate Scientist to join our team. We use our pioneering XmAb® technology to develop better biotherapeutics – antibodies that target new biological mechanisms and have the potential to be more potent, safer and longer lasting – with the goal of improving 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 enabled multiple collaborations with leading biopharmaceutical companies including Novartis, Amgen, Morphosys, 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.
BioAnalytical Development Group in Preclinical Sciences is seeking a highly talented and motivated Senior Associate or Associate Scientist with expertise in method development and performance of cell based and ligand binding assays for release and stability testing of all of Xencor’s products. Expertise in Design of Experiments (DoE) for assay optimization and experience in multiple formats is preferred. The individual is expected to work with cross-functional teams for biotherapeutic products at various stages of research and development with minimum supervision. This position is located at Xencor’s headquarters in Monrovia, CA.
• Develop and optimize cell based and ELISA based potency assays and nAb assays to support drug development programs.
• Qualification and transfer of assays internally or to a CRO.
• While this position focuses mainly on cell based potency assays, the candidate is expected to develop and optimize immunoassays to support PK and ADA analysis as well.
• Thorough knowledge of relative potency assays in large molecule drug development
• Knowledge of Ligand Binding Assays (immunoassays) used in Pharmacokinetic analysis and relative potency determination.
• Must be proficient in use of SoftMax Pro, GraphPad Prizm.
• Analyze and report data as per established timelines
• Maintain mammalian cell cultures; generate master and working cell banks
• Maintain reagent inventory and laboratory equipment
• Follow developing and established standard operating procedures in a regulated laboratory (GMP). Experience with handling non- conformances (NCs) and Corrective and Preventive Action (CAPA) plans is a plus.
• Maintain compliant records
• Author and review technical study reports and regulatory submissions
• Maintain current knowledge of the field and area(s) of scientific expertise and development
• Interact with multidisciplinary functions (QA, CMC, Sample management, and research) as needed.
• Bachelor’s degree in biological sciences with 10+ years Industry experience or Master’s degree in Biological sciences with 5+ years Industry experience.
• Experience in design, development, and execution of assays for large molecule drug development
• Experience in Bioassays (e.g. neutralizing antibody, phosphorylation, caspase, cytotoxicity, ADCC, reporter expression, cell proliferation) in a regulated medical/research lab desired.
• Experience in Immunoassays in multiple platforms (e.g. ELISA, MSD, TRF, SPR)
• Proficient in common software and data analysis packages (eg, SoftMax Pro, GraphPad Prism, JMP; Microsoft Office: PowerPoint, Excel, Word, Outlook)
• Detail oriented, good documentation practice and strong organizational skills
• General lab experience including operating basic laboratory equipment such as pipettes (precision pipetting), centrifuge, and microscope.
• Strong interpersonal skills and ability to work well in a team
• Excellent verbal and written communication skills