What are the responsibilities and job description for the Senior Sterile Drug Product Process Expert position at O2 Technologies,Inc?
Key Responsibilities & Skills
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
- Sterile Drug Product Formulation
- 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
- Minitab / JMP
- Ishikawa Analysis
- Kepner-Tregoe (KT) Methodology
- Five-Whys Technique
- GxP Compliance
- Microbiology Techniques
- Extractables/Leachables Analytical Methods
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
- Aseptic Fill/Finish
- Contract Development & Manufacturing Organizations (CDMO)
- Regulatory Affairs
- Quality Assurance