Senior Sterile Drug Product Process Expert

Key Responsibilities & Skills Sterile Drug Product FormulationAseptic Fill/Finish Process DevelopmentProcess Oversight of CMO SitesContinuous Process VerificationProcess Risk AssessmentDeviation Investigation & Root Cause AnalysisChange Implementation & Continuous ImprovementCross-functional Team CollaborationRegulatory Filings (CMC) ExpertiseContainer Closure & Single-Use Technology KnowledgeExtractables/Leachables (E/L) Risk ManagementProject Management & Multi-Project CoordinationQuality Assurance Interface Technical Skills Minitab / JMPIshikawa AnalysisKepner-Tregoe (KT) MethodologyFive-Whys TechniqueGxP ComplianceMicrobiology TechniquesExtractables/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 / BiotechSterile Drug ManufacturingAseptic Fill/FinishContract Development & Manufacturing Organizations (CDMO)Regulatory AffairsQuality Assurance #CareerOpportunities #JobVacancy #WorkWithUs