Senior Scientist, Quality CMC

Role: Senior Scientist, CMC Quality, providing scientific leadership in analytical sciences and product quality investigations within biopharma manufacturing. Responsibilities include leading complex investigations of OOS, OOT, deviations, and stability trends; connecting analytical findings to process variability and formulation behavior; and supporting regulatory submissions (IND/NDA/MAA) and compliance. The role involves partnering cross-functionally with QC, R&D, Engineering, and Regulatory teams to ensure risk-based decision-making throughout the product lifecycle. Qualifications: BS in Chemistry, Pharmaceutical Sciences, or related field; minimum 8 years in pharmaceutical/biotech Quality Control, CMC, or Analytical Sciences; proven experience in complex investigations, root cause analysis, and scientific rationales; strong understanding of GMP, regulatory standards (FDA, EMA, ICH), and analytical techniques (e.g., HPLC, GC). Preferred skills include experience with stability programs, trend analysis, and supporting regulatory audits. The role requires a deep understanding of method capability versus product behavior, as well as influence across cross-functional teams. Travel may be required. High-value: biopharma CMC, analytical investigations, stability and process variability, regulatory submissions, and method limitations.