Principal Research Scientist I - Analytical R&D

Role: Principal Research Scientist I, Process Analytical Technology (PAT), to lead a small team supporting drug substance and drug product development for synthetic molecules. Objectives include establishing and executing PAT strategies across development stages, from early development to manufacturing validation and technology transfer. Responsibilities involve leading PAT method development, validation, lifecycle management, and integration with process understanding; mentoring team members; collaborating with cross-functional teams such as Process Engineering, Process Chemistry, Manufacturing, Quality, and Regulatory; and advancing PAT innovations, including spectroscopic and on-line analytical techniques like NIR, Raman, FTIR, UV-vis, and UHPLC. Qualifications include a Ph.D. or equivalent with at least 6 years (Ph.D.) or 12+ years (MS/BSc) industry experience in pharmaceutical PAT, analytical chemistry, or related fields; strong expertise in chemometrics, data analysis platforms (e.g., MATLAB, Python, R), and spectroscopic techniques; experience with biologics or new modalities is preferred. The role requires proven leadership in technical project execution, cross-functional collaboration, and regulatory understanding of pharmaceutical development and validation. High-value aspects: biologics and small molecules, synthetic drug programs, development to validation phases, regulatory compliance with GxP, and a focus on process understanding and control strategies. The position may include some travel; work setup details not specified.