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President
Cell Therapy & Biologics, Technology Transfer, Validation, Technical Investigations, Regulatory Submissions, Strategy
Sr. Consultant
Quality By Design, Product Characterization, Analytical Development, Regulatory Submissions
Cell Therapy, Gene Editing, Vaccines, Viral Vectors, Analytical development, Method Qualification, Method Validation
Sr. Consultant
Characterization/Comparability, Method Lifecycle Management, Regulatory Submissions, QC, Technical Documentation
GMP Audits, Data Integrity, PAI & GMP Inspection Prep, GMP Gap Assessment & Remediation, GMP-Intelligence
Quality Assurance, Quality Control, Quality Systems, Audits & Inspections, Regulatory Requirements
Biologics cGMP Manufacturing, Cell and Gene Therapy, Technology Transfer, Investigation, Change Control, Operations Management
Quality Assurance, Quality Control, Quality system, GMP Audits & Inspections, PAI, Regulatory Requirements
Prin. Consultant
Biologics & Viral Products, Expression Systems, Cell Banking, Technology Transfer, Regulatory Submissions
Protein Engineering, Mammalian & E. coli expression, Formulation, Refolding, Downstream Development, Analytical Development, Strategy.
Clinical Development, Pharmacovigilance, Clinical Safety, Medical Affairs, Business Development, Licensing
Biologics, Biologics Process Design, Microbial Process Development, Statistical Data Analysis, Statistical Design Of Experiments
Consultant
Quality Assurance, Supplier Quality Management, Validation, Change Control, CAPA, Project Management
Formulation Development, Drug Product Development, High Throughput Screening, High concentration/viscosity, Co-formulation, Viral Vectors
Cell and Gene Therapy, Analytical Development, Product Characterization, Control Strategy, Method qualification and validation, CMC strategy
Cell & Gene Therapy, CMC Strategy, Product Development, Regulatory Submissions
Bioassay & Potency Assay Development, Transfer & Qualification, QC Implementation, Biological Characterization & Comparability, Biosimilarity
Cell Therapy, Product Development, Risk Assessment, Regulatory Submissions, Project Management
Biologics, Formulation, DP Development, Lyophilization, Analytical Development, Comparability, Characterization
Quality Assurance, Quality Agreements, Validation, SOPs, Change Control, Deviations, Data Review
Process Architect
Facility Design, cGMP Programming, Feasibility Layouts, Equipment Space Testing, Containment Design, Facility Gap Analysis
CMC Statistics and Data Analytics, Data Processing Automation, Business Intelligence, Process Characterization, Data Governance