Associate Principal Scientist, Upstream Development

Job Description: The Biologics Process Research & Development organization within our company's Research Laboratories is responsible for developing the drug substance manufacturing processes for our company's biologics pipeline. We work closely with colleagues in Discovery, Pre-clinical and Early Development to rapidly develop manufacturing processes for biotherapeutics and efficiently manufacture material to supply clinical trials. We are also responsible for commercial process development and development and implementation of new manufacturing technologies. We work with our partners in our company's Manufacturing Division to commercialize and launch new products. We are seeking a highly motivated and energetic individual to join our Biologics Process Development Department as an Associate Principal Scientist. Applicant must have effective organizational and multi-tasking skills, demonstrated excellent scientific leadership in Upstream process development, and superior written and oral communications abilities. Evidence of strong cross-functional collaboration, significant external presence with scientific excellence, and interest and abilities for mentoring junior staff are also expected. In this role, the successful candidate will work closely with a highly motivated team of Scientists and Engineers in the Upstream Process Development area and contribute to CMC development of our company's pipeline, playing an active role in the design, development, and optimization of cell culture processes and the transfer of processes to clinical and commercial manufacturing sites. She/He will also participate in developing and refining strategies related to next-generation processes through technology development initiatives for assets in early and late-stage clinical development. Responsibilities include, but are not limited to: Participates in and/or leads upstream process development of first-in-human and commercial processes by efficiently developing high yield, robust, and scalable cell culture processes. Responsible for process development, process characterization, and regulatory filing activities to ensure a smooth and clear path to successful PPQs and BLAs for the company's pipeline. Partner with colleagues in Discovery, Cell Line, Downstream Process Development, Analytical Sciences, and Manufacturing to develop integrated clinical and commercial process and manufacturing solutions that achieve quality by design targets with robust control strategies. Advancing the upstream platform processes through creative process improvement initiatives to increase operational efficiency and reduce costs. Collaborate with academia, industry partners, and vendors to drive development, innovation, and adoption of new process technologies. Keep up to date with the external patent and literature environment; actively present and publish externally and pursue patenting strategies. MINIMUM EDUCATION REQUIREMENTS: Ph.D. with 4+ years' experience or Master's with 8+ years' experience or a bachelor's with 12 years of experience in chemical engineering, Bioengineering, Biological Engineering, or a related field REQUIRED EXPERIENCE AND SKILLS: Technical background and hands-on experience with mammalian cell culture and fed-batch processes to produce recombinant proteins. Scientific understanding and working knowledge of CHO cell biology, metabolism, cell culture media and engineering principles for large scale recombinant protein production systems. Working knowledge of statistical methods (design of experiment, multivariate data analysis) and tools (SIMCA, JMP, etc.). Understanding of cell culture bioreactors including microbioreactors, bench-scale and pilot-scale bioreactors, and bioreactor scale-up principles from laboratory to large scale. Proven track record of accomplishments in upstream process and technology development with a strong scientific publication and presentation track record. Ability to direct the planning,