Senior Staff Scientist Cell Therapy Analytical Method Development

In Bayer’s Pharmaceuticals division, we focus on researching, developing, and marketing specialty-focused innovative medicines that provide significant clinical benefit and value, primarily in the therapeutic areas of cardiology, oncology, gynecology, hematology, and ophthalmology. With our innovative products, we seek to achieve therapeutic benefit for patients, while at the same time satisfying the growing requirements of physicians and health insurers. As one of the leading research-based pharmaceutical companies worldwide, we have nearly 50 ongoing development projects in clinical trials.

Bayer’s cell culture team supports the development of emerging therapies in Bayer's portfolio with an emphasis on oncology, cardiology and additional specialty care therapeutic areas. We work closely with a network of health care professionals, patients, academic centers, other pharmaceutical companies, and innovative biotech organizations to bring innovative treatments to market. By combining automation, digital capabilities and single-use bioprocessing technologies, we streamline production to bring new medicines to patients faster.

YOUR TASKS AND RESPONSIBILITIES

The primary responsibilities of this role, Staff Sci Cell Therapy Analytical Development (Microscope/Cellular Imaging), are to: 

• Be a Subject Matter Expert (SME) for the development and qualification/validation of assays for Cell Therapy with focus on methods using a variety of microscopic technologies, e.g. live cell imaging and high-resolution microscopy, including method transfer from/to external/internal labs as needed
• Perform testing of raw material, starting material, process intermediates and final cell therapy products such as CAR-T cells and iPSCs;
• Develop and run tests support cell therapy process development (ddPCR assays, flow cytometric assays, ELISA, etc.);
• Authoring SOPs, development report, qualification, and validation reports;
• Design and conduct experiments, assays, or operational procedures of considerable complexity with considerable discretion as to work details requiring complicated scientific analysis, operational planning, and execution;
• Exercise sound technical judgment to solve a wide range of complex scientific problems.  Recommend new and innovative solutions to problems utilizing high degree of scientific creativity, independent thought, and proficiency.  Identify technology gaps and makes recommendations to management;
• Keep abreast of current and new science and technological developments with regard to literature/publication within the field of cell and gene therapy analytical development;
• Communicate and present complex scientific findings and recommendations in one-on-one discussions, and departmental, functional and international meetings;
• Ensure that laboratory notebooks are consistently updated, audited and well-maintained.

WHO YOU ARE

Your success will be driven by your demonstration of our LIFE values.  More specifically related to this position, Bayer seeks an incumbent who possesses the following:

Required Qualifications:

• B.S. in Biological Sciences, Biochemistry, Molecular Biology, Chemistry, or related field with a minimum of ten years of relevant experience in biopharma, healthcare or manufacturing environment OR M.S. with a minimum of six years of relevant experience OR Ph.D. with a minimum of four years of relevant experience OR an equivalent combination of education and experience;
• Demonstrated expertise and hands-on experience in the development of quantitative imaging assays for the characterization of cell therapy products, e.g. methods with live cell imaging and high-resolution microscopy;
• Experience in developing other analytical methods for cell therapy products, e.g. cell-based functional assays, q-PCR/ddPCR assays, flow cytometric assays.
• Knowledge of GLP/GMP guidelines as applied to the testing of biologics molecules;
• Experience in writing protocols/reports/SOPs and scientific presentations;
• Up-to-date knowledge in scientific and technological developments with regard to cell and gene therapy analytical development;
• Ability to identify gaps in technology and operational systems and solve complex and diverse operational and scientific problems requiring original thinking and deductive reasoning 
• Profound experience in development and qualification of assays using a variety of microscopic technologies, especially Sartorius Incucyte or similar;
• Hand on experience in development of cell-based functional assays, handling human cells/cell lines including PBMC, CAR-T cells, iPSC;
• Excellent verbal and written communication skills including writing of scientific and technical reports and presentations;
• Based on scientific understanding of the process, applies GMP requirements to analytical method development, clinical manufacturing, and process/assay transfer activities;
• Understand how GMP requirements are applied to practice over entire analytical development cycle.