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.
The primary responsibilities of this role, Staff Scientist Cell Therapy Analytical Development Cell Based Potency Assays are to:
- Lead the development and qualification of platform assays for Cell Therapy with a focus on cell based functional assays, flow cytometry and/or ddPCR;
- Perform testing of raw material, starting material, process intermediates and final cell therapy products such as CAR T cells and iPSCs.
- Author SOPs, development, qualification and validation reports.
- Independently 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 make 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.
- Effectively communicate 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.
- Work on problems of diverse scope in which analysis of situations or data requires evaluation of identifiable factors.
- Exercise judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
- Demonstrated success in technical proficiency, scientific creativity, collaboration with others and independent thought.
WHO YOU ARE
Your success will be driven by your demonstration of our LIFE (Leadership, Integrity, Flexibility, Efficiency) values. More specifically related to this position, Bayer seeks an incumbent who possesses the following:
- Bachelor's degree, Master's degree OR Ph.D. in a life science or engineering discipline - (bio /chemical engineering, biotechnology etc.).
- Hands-on experience in the development of assays for the characterization of cell therapy products.
- Experience in developing cell based functional assays OR flow cytometry OR qPCR/ddPCR assays.
- Thorough knowledge of GLP/GMP guidelines as applied to the testing of biologics molecules.
- Skilled in writing protocols/reports/SOPs.
- Ability to identify gaps in technology and operational systems and solve complex and diverse operational and scientific problems requiring original thinking and deductive reasoning.
- Knowledge of cell biology/immunology.
- Hands on experience in handling human cells/cell lines such as CAR T cells, stem cells, PBMCs, Cell based assays, Flow cytometry, ddPCR, Protein biochemistry and cell culture.
- BS degree with 8 years, MS degree with 6 years or Ph.D. with 4 years of relevant experience in the biopharmaceutical industry or an equivalent combination of education and experience.
- Experience with live cell imaging and high-resolution microscopy is a plus.
Employees can expect to be paid a salary between $111,200 - $166,800. Additional compensation may include a bonus or commission (if relevant). Additional benefits include health care, vision, dental, retirement, PTO, sick leave, etc. This salary range is merely an estimate and may vary based on an applicant’s location, market data/ranges, an applicant’s skills and prior relevant experience, certain degrees and certifications, and other relevant factors.
Bayer is an Equal Opportunity Employer/Disabled/Veterans