Our Team

Cell Therapy & Biologics,  Technology Transfer, Validation, Technical Investigations, Regulatory Submissions, Strategy

Process & Analytical Development, Technology Transfer, cGMP Manufacturing, Project Management, Cell Culture, Microbial Fermentation, Monoclonal antibodies, ADC’s, mRNA and Lipid Nanoparticles.

Cell and Gene Therapy, Technical Operations, CMC, Process Development, Regulatory Filings, CDMO oversight

Program Leadership & Execution, CDMO Management, Portfolio Management, Strategy Development, Operational Excellence

Biologics, Biologics Process Design, Microbial Process Development, Statistical Data Analysis, Statistical Design Of Experiments

Cell and Gene Therapy, Allogeneic CAR-T, Process Development, Lipid Nanoparticles, Due Diligence, Technology Roadmap

Biologics, Formulation, DP Development, Lyophilization, Analytical Development, Comparability, Characterization

Facility Design, cGMP Programming, Feasibility Layouts, Equipment Space Testing, Containment Design, Facility Gap Analysis

Bioassay & Potency Assay Development, Transfer & Qualification, QC Implementation, Biological Characterization & Comparability, Biosimilarity

Cell Therapy, Gene Editing, Vaccines, Viral Vectors, Analytical development, Method Qualification, Method Validation

Quality Assurance, Quality Control, Quality system, GMP Audits & Inspections, PAI, Regulatory Requirements

Clinical Development, Pharmacovigilance, Clinical Safety, Medical Affairs, Business Development, Licensing

Cell & Gene Therapy, CMC Strategy, Product Development, Regulatory Submissions

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Cell & Gene Therapy, Regulatory Strategy, Process Characterization & Validation, FDA Inspection Readiness, PAI, Biologics

Process Design, Process Development, CMC, Biologics, CDMO Selection & Management, Process Characterization

Project Management, Tech Transfer, Cell Therapy, CAR-T, Lentivirus, Risk Based Approach, Process modeling, technical writing, CMC, Smartsheet

Biologics Development & Manufacturing, Expression Systems, Cell Banking, Biosimilar Development, Upstream

Cell Therapy, Product Development, Risk Assessment, Regulatory Submissions, Project Management

CMC Statistics and Data Analytics, Data Processing Automation, Business Intelligence, Process Characterization, Data Governance

Biologics cGMP Manufacturing, Cell and Gene Therapy, Technology Transfer, Investigation, Change Control, Operations
Management

Characterization/Comparability, Method Lifecycle Management, Regulatory Submissions, QC, Technical Documentation

Biomarker Strategy, Discovery, Validation, & Drug Development, Multi-Omics & Companion Diagnostics, Personalized Medicine

Quality Assurance, Quality Control, Quality Systems, Compliance Audits & regulatory Inspections, Regulatory Requirements

Biologics manufacturing, Process Development, Fermentation, CHO cells, ADC, Fusion proteins, Monoclonal antibodies, CMC regulatory

Process Development, Technology Transfer, CMC Regulatory, CDMO Management, Due Diligence, Facility Fit

Cell Therapy Development, Risk Assessment, Technical Document Authorship & Management, Cell Culture, Project Management

Cell & Gene Therapy, Viral Vectors, Vaccines, Process & Analytical Development, Tech Transfer, CDMO/CTO management, CMC Strategy

Biologics & Viral Products, Expression Systems, Cell Banking, Technology Transfer, Regulatory Submissions

Formulation Development, Drug Product Development, High Throughput Screening, High concentration/viscosity, Co-formulation, Viral Vectors

Cell and Gene Therapy, CAR-T, Technology Transfer, Process Characterization, Process Control, Life Cycle Management

Technical Operations, Facility and Process Design, Capital Projects, Process and User Requirements, Technology Development and Readiness, CDMO Management

Quality By Design, Product Characterization, Analytical Development, Regulatory Submissions

Quality Assurance, Biologics & combo. products, Inspection prep. & mgmt., Supplier mgmt., Quality Systems, Analytics & commercialization

Quality Assurance, Supplier Quality Management, Validation, Change Control, CAPA, Project Management