Associate Director, Raw Materials MSAT

Role: Associate Director, Raw Materials Lead, responsible for developing and executing technical strategies and lifecycle management programs for raw materials in GMP biologics manufacturing. Objectives include ensuring product quality, process robustness, and regulatory readiness for BLA submissions and commercial launches. Responsibilities encompass establishing material control frameworks, leading cross-functional initiatives with Quality Assurance, Supply Chain, and Regulatory teams, managing extractables/leachables and visual inspection programs, defining critical material attributes, conducting risk assessments, and supporting regulatory interactions. The role also involves leading investigations, CAPA initiatives, and driving continuous improvements. Key collaboration partners include Manufacturing Operations, QC Microbiology, MSAT, Facilities, Engineering, and Regulatory Affairs. The leadership aspect involves building and managing a high-performing raw material team, developing training programs, and fostering a proactive quality culture. Qualifications include a Bachelor's in Biological Sciences, Engineering, or Pharmaceutical Sciences, with 10+ years of experience in biologics or cell/gene therapy, especially supporting autologous therapies and late-stage development activities. Deep expertise in CMC processes, raw material risk management, and GMP compliance for biologics or cell therapies is required. Preferred skills include strong organizational, communication, and influence abilities, with experience leading teams and interacting with regulatory authorities. The position supports strategic planning for manufacturing readiness and network expansion, emphasizing risk mitigation and continuous improvement within high-pressure GMP environments.