Process Development Senior Scientist - Pre-Pivotal Drug Product Technologies

Role: Process Development Senior Scientist focusing on early-stage biologic drug product formulation and process development, primarily for monoclonal antibodies, multispecifics, and related modalities. Objectives include designing liquid and lyophilized formulations, optimizing scalable fill/finish processes, and supporting regulatory submissions. Responsibilities encompass developing and characterizing formulations, evaluating CQAs (aggregation, fragmentation, particle formation), and building process understanding through automation, high-throughput screening, and advanced data analytics, including AI/ML applications. The role involves collaboration across process development, research, regulatory, and manufacturing teams to advance biologics from discovery through clinical manufacturing, with a focus on stability, product quality, and technology transfer. Qualifications: Doctorate (PhD, PharmD, MD) or Master’s with 3+ years, or Bachelor’s with 5+ years of scientific experience; expertise in biologics formulation, stability, and fill/finish is required. Preferred skills include hands-on experience with high-throughput automated workflows, laboratory robotics, in silico modeling, and analytical techniques such as UPLC, SEC, IEX, and subvisible particle analysis. Experience with clinical-stage development, process risk assessment, and regulatory documentation is highly desirable. The position emphasizes innovation in workflow automation, digital tools, and biophysical characterization to accelerate biologics R&D. The work setup is not specified, and travel requirements are not detailed.