Sr. Scientist, Drug Product, MST

Role: Manufacturing Science and Technology (MST) specialist supporting large molecule Drug Product manufacturing, focusing on lyophilization, liquid processing, aseptic filling, and quality investigations. Responsibilities: provide technical support for technology transfer and lifecycle management, troubleshoot aseptic processes, author process documents, monitor process data for continuous improvement, support validation activities (IQ/OQ/PQ, CPV), and assist regulatory audits. Collaborate cross-functionally with Manufacturing, Quality, Engineering, Validation, and Supply Chain, and may guide junior staff. Requirements: Bachelor's degree with 4+ years in pharmaceutical Drug Product manufacturing; master's preferred. Skills include GMP systems, process troubleshooting, risk assessments, and data analysis with Excel and statistical tools (JMP/Minitab). Experience in sterile drug manufacturing, aseptic techniques, and process validation is essential. Preferred: familiarity with SAP, Veeva, electronic batch records. Travel up to 5%. Focus on biologics/drug products in GMP environment, emphasizing process validation, quality systems, and regulatory compliance.