Sr Scientist, Process Development

Role: Senior Scientist in Cell Culture Process Development, focusing on pivotal and commercial stages for biologics, including monoclonal antibodies and novel modalities. Responsibilities: optimize and characterize cell culture processes for supply during clinical trials and commercialization, lead process risk assessments, process characterization, and support regulatory documentation such as BLA submissions. Support technology transfer, investigate process improvements, design experiments across various bioreactors and platforms, and contribute to process validation and scale-up activities. Mentor junior team members and collaborate cross-functionally with manufacturing sciences, regulatory, and other departments. Requirements: Bachelor's degree with 8+ years or Master’s degree with 6+ years of industry experience; PhD/PharmD with 3+ years preferred. Technical expertise in cell culture, process development, bioreactor operation (shake flask to pilot scale), statistical modeling, and regulatory documentation. Preferred skills include hands-on experience with high-throughput bioreactors, cell culture media development, process modeling, and experience with viral vaccines. HighValue: biologics, monoclonal antibodies, cell culture process development, GMP, pivotal stage, regulatory submission support, cross-functional collaboration, team leadership. WorkSetup: On-site with some travel to support technology transfers and external manufacturing oversight.