Principal Engineer--Process Development

Job Category: Biotech/R&D/Science Company: Baxter Healthcare Reference Code: 30927BR-1 Principal Engineer--Process Development Baxter International Inc., assists healthcare professionals and their patients with the treatment of complex medical conditions, including cancer, hemophilia, immune disorders, kidney disease and trauma. The company applies its expertise in medical devices, pharmaceuticals and biotechnology to make a meaningful difference in patients' lives. The Baxter Hayward facility manufactures therapeutic monoclonal antibodies and proteins from mammalian systems. A Process Development Principal Engineer position is currently open in process development department. The Process Development Principal Engineer will be responsible for Process development, Process Support, process scale up and Process Transfer activities. The person will be responsible for planning, designing, and conducting experiments with emphasis on process optimization and improvement, scaling-up, process transfer and trouble-shooting. This person will apply expert knowledge and skills in process transfer activities and large scale manufacturing purification support that will lead to robust manufacturing purification operations for therapeutic antibody and protein products. This person will be constantly involved in inter-departmental communications between process development department and manufacturing department within Hayward plant, as well as between Hayward plant and other Baxter/client process development/manufacturing teams for various projects. Major reponsibility includes: Design and conduct studies in both column chromatography and non-chromatography related downstream process steps in both small-scale and intermediate scale operations with focuses on identifying critical scale up process parameters, requirements, optimizing process, and developing scalable, transferable purification processes. Executing studies on the manufacturability, scalability, and robustness of the purification process Provide support to improve current processes in existing operations or to transfer new processes into manufacturing. Communicating with downstream manufacturing department, conducting investigation and data analyses, trouble-shooting manufacturing purification processes; Evaluate new manufacturing technologies as well as current commercially available technologies for rapid implementation into manufacturing operations. Make recommendations to operations management for continuous process improvements. Modify and adapt commercially available technologies for implementation. Evaluate scientific data and apply knowledge and skills to make appropriate decisions for optimal process improvements. Provide support to scale-up, process transfer and documentation. Prepare technical documents.Participate in constant floor support for large scale purification process Contribute to manufacturing purification process trouble shooting with focus on process scale up and any engineering related issues. Participate in manufacturing OOS investigation related to downstream purification process, responsible for resolving exceptions and write exception reports to address process transfer, scale-up, operation related issues. Writing, reviewing, revising, and/or approving purification protocols, purification transfer documents, technical reports; Oral and written presentations & communications to internal manufacturing department or external scientific community. QUALIFICATIONS: Engineering or scientific degree with relevant experience in a relevant discipline: Chemical Engineering, Biomedical Engineering, Industrial Engineering, Biochemistry, Chemistry, Mechanical Engineering, etc., plus large scale purification and/or engineering experience in the biopharmaceutical industry. Bachelor's degree with at least 10 years of industrial experience, Master's degree with at least five years industrial experience, or Ph.D degree with at least 2 years of industry experience in biopharmaceutical cGMP working environment with primary focus on therapeutic protein & antibody process development & process engineering Have extensive knowledge, expertise and experience in therapeutic antibody or protein purification process development, optimization, scale-up and process transfer The candidate must be very familiar with downstream process development equipments including bench-scale AKTA equipment, AKTA process skids, small and large-scale filtration devices from major vendors, filtration membranes, depth filtration process, TFF process, and nanofiltration-related equipments currently used in the biopharmaceutical industry; have adequate knowledge and experience in using a variety of chromatography methods/resins to develop purification processes. Be familiar with FDA guidance and requirements for developing a successful therapeutic antibody/protein purification process. Candidates must have the ability to work independently, have leadership experience in managing process development projects related to process engineering aspects, have strong trouble-shooting and problem-solving skills, and be able to work well with multi-cross-functional work teams in a fast-pace environment. Excellent written and verbal communication skills are required. As a global leader dedicated to building the best team in health care, Baxter offers competitive compensation and full benefits. To view other opportunities at Baxter, please visit our Careers@Baxter site. EOE M/F/D/V.