Scientist

DescriptionProcess Validation Scientist - Official Title/RoleDemonstrate specific upstream cell culture and downstream purification unit operations knowledge in support of bioprocessing of large molecule biologics.Lead Process Validation (Stage 3) activities including:process validation strategiesprotocols/reports review/approvaltimely generation of Chemistry Manufacturing and Controls (CMC) documentationcollaboration between Manufacturing Sciences and Technology (MS&T), Manufacturing Regulatory and Qualityprovides statistical support for product monitoring using techniques including statistical process control, process capability analysis, non-linear and linear regression and significant tests.process investigation PV impact assessment strategiesCollaborate with global process validation team.Communicate CPV trends to Quality Management and CMC teams.Present/defend process validation packages and strategies during audits and inspections.Review/approve technical reports and deliver presentations utilizing sound compliance reasoning and interpretation of the available data.Essential For The RoleBachelor’s Degree preferably in Science or Engineering. Master’s Degree or PhD preferred.At least ten (10) years of overall experience in Scientific / Biotech / Pharmaceutical field with at least five (5) years of experience in Process Validation.Comprehensive knowledge PPQ and CPV regulatory expectations.Fundamental understanding of upstream and downstream process units for biopharmaceutical products.Broad understanding of Chemistry Manufacturing and Controls (CMC) activities and responsibilities with respect to Process Validation/Process Performance Qualification.Knowledge of GMP manufacturing principles and documentation.Proficient in statistical tools and techniques commonly used in the Biotech industry.Ability to apply critical thinking to solve problems and work independently.Strong interpersonal and communication skills.Shift1st Shift M- F 9 - 5 (at site)Preferred ExperienceMasters degree.3 - 6 years experience in biopharmaceutical Process Validation, Continued Process Verification role either as practitioner or Quality Assurance.Strong technical writing and collaboration.Regulatory experience is a plus.Statistics experience is a plus.

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