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Quality Assurance, Regulatory Affairs, and New Product Development Consultant
BS Engineering, 30+ years in senior technical/management positions in Quality Assurance, Regulatory Affairs, and New Product Development space. Expert in medical device, in-vitro diagnostic, and pharmaceutical products and processes. Core competencies in Design Control, Risk Management, Validation and Verification, and…
Pulmonary Hypertension Drugs, Nitric Oxide and Nitric Oxide Delivery Systems
Seasoned Executive with a unique combination of scientific and business expertise in the pharmaceutical industry. Over 18 years of drug development experience (i.v, subcutaneous, inhaled and oral products), 15+ years in Pulmonary Hypertension, including 10 years in years at a…
Sterile Process Validation, Microbiology, Steam Sterilization, Aseptic Filling, Rapid Micro Methods
Expert has over 25 years experience in various aseptic of sterile process validation. She has worked for Baxter, Fujisawa (now Astellas), Jordan Pharmaceuticals, Vectech Pharmaceutical Consultants and Excellent Pharma Consulting. This encompasses steam sterilization, aseptic filling, process validation, development of…
HVAC and Refrigeration, Process Piping and Plumbing, Cleanroom Design, Hazard Occupancies, and Codes and Standards
Expert is principal and founder of a consulting LLC and is a consulting Mechanical Engineer specializing in the built environment; Expert provides: - Project Design and Management Consulting - Forensic Analysis and Litigation Consulting - Expert Testimony at Legal Proceedings…
Product Development and Regulatory Approval of In-Vitro Diagnostics and Companion Diagnostics
PhD in Biochemistry, MBA in Business and RAC (US) Certification with 15 years of experience in diagnostic assay and system development at top global in-vitro diagnostic (IVD) companies including Roche, Bio-Rad Labs, Siemens Healthcare Diagnostics and Employer. A proven track…
Web Application Development, Online Advertising, Software Development, Digital Library Software
Expert has over ten years of Javascript programming experience, delivering production code delivered to hundreds of millions of computers, and developing complex web applications and frameworks.
Global Procurement, Chemical Engineering, Manufacturing, Chemicals, International operations,
With over 17 years of experience managing new product development teams, Expert is currently Vice President of Research and Development. He is responsible for strategy, the new product pipeline, project management, resource allocation, product innovation, and intellectual property. His team…
Clinical Development, Safety Reviews, Pharmacovigilance, Pharmacoeconomics
• Employer for preparation for an FDA Advisory Committee regarding review of an NDA. • Design and implementation of Phase I-IV clinical studies • Employer to many large pharmaceutical companies • Employer to Biotechnology companies and CROs • Medical safety…
Biochemistry, Drug Development, Antibiotics, Proteins, Medicines, Pathogens, and Pharmaceuticals
Expert serves on the faculty of a University, Department of Chemistry and Chemical Biology. He previously held a senior scientist and lecturer position at ETH Zurich, Switzerland. His interests are at the interface of chemistry and biology, where he is…
Plumbing, Electric, HVAC, Carpentry, General Construction
Expert brings over 40 years of experience in the construction industry to the table. Expert began his career with hands-on, trade level experience in electrical, carpentry, HVAC, and plumbing work. After retiring the tools, he moved into managerial positions with…