Senior Sterile Drug Product Process Expert

Key Responsibilities

• Aseptic Fill/Finish Process Development
• Process Oversight of CMO Sites
• Continuous Process Verification
• Process Risk Assessment
• Deviation Investigation & Root Cause Analysis
• Change Implementation & Continuous Improvement
• Cross-functional Team Collaboration
• Regulatory Filings (CMC) Expertise
• Container Closure & Single-Use Technology Knowledge
• Extractables/Leachables (E/L) Risk Management
• Project Management & Multi-Project Coordination
• Quality Assurance Interface Technical Skills

Skills

• Minitab / JMP
• Ishikawa Analysis
• Kepner-Tregoe (KT) Methodology
• Five-Why Technique
• GxP Compliance
• Microbiology Techniques
• Extractables/Leachables Analytical Methods

Education

Bachelor's Degree in Pharmaceutical Sciences, Chemical Engineering, Pharmaceutics, Process Engineering.

Preferred: M.S. in Pharmaceutical Sciences, M.S. in Chemical Engineering, Ph.D. in Pharmaceutical Sciences, Ph.D. in Chemical Engineering.

Industry Experience

Pharmaceutical / Biotech

Sterile Drug Manufacturing

Contract Development & Manufacturing Organizations (CDMO)

Regulatory Affairs

Quality Assurance