Pharmaceutical Regulatory Affairs Consulting in: Project Management, Quality and Compliance - NDA, ANDA, DMF and eCTD - Domestic and InternationalHigh-performing Regulatory Affairs and Compliance Professional with over 25 years of diverse pharmaceutical experience in sterile injectable, solid dosage, oral solution, and inhalation product environments. Demonstrated knowledge of regulations and the NDA/ANDA/DMF eCTD submission process with a successful track record in obtaining over 200 drug product approvals. Proven expertise in negotiating effectively with the U.S. FDA applying broad understanding and experience in handling p...

Biological Manufacturing: Auditing, Root Cause Analysis, Corrective, Preventative Action and GxP compliance. Biological and clinical manufacturing operations executive, providing a wide range of experience in quality leadership across many facets. Create, develop and recommend program and system changes pertaining to vaccine product release and deviation management resulting in more efficient product release to market and improved "right-first-time" manufacturing metric. Articulate leader with unparalleled work ethic coupled with a strong sense of urgency, keen interest and passion in making quality a key ingredient to the success of...

Lab Testing Design: Drugs-Pharmaceutical Testing, Lab Operations, Maintenance, and Quality Control of Drug Testing Labs: Toxicology, Cannabis, Bioequivalence), Regulatory Requirements, BioequivalencSummary Over 17 years of drug testing experience on the development, validation, and application of analytical methods.  Equal experience in drug testing Labs design, operation, maintenance, and quality control of drug testing labs: Toxicology, cannabis, drugs, bioequivalence), cannabis regulatory requirements, bioequivalence studies, quality control studies, analytical laboratories’ quality assurance procedures.&n...

Multi-Disciplined Expert Working in the Health, Energy, Environment, Advanced Material-Coatings Industries covering areas in: Biomaterials and Bone Tissue Engineering, Drug Delivery, BiodegradablesSummary Materials Science, Technology and Manufacturing Engineer in Research and Development, (R&D) providing over 27 years of experience working in the industry and academia, Included in Stanford University’s List of World’s Top 2% of Scientists, USA Metallurgy engineering, coatings and corrosion consultancy: Providing graduate level  educational in the STEM area, maintaining a high standard of quality and connecting R&D....

Doctorate in Biochemistry Experience in Academics, Biomedical Research, Process Development (Upstream and Downstream) of Bacterial Vaccines and Protein Therapeutics for Scale Up to ManufacturingIndustrial Biotechnology  Biotechnology facility design and layout, overall planning, project conception, budgeting and execution.  Over twenty tears of industrial experience in-process development of vaccines and biologicals in leading companies.   Research and development biotechnology management and transfer. Process development and optimization for bacterial vaccines.  Vaccine’s manufacturing unit layout an...

Process Development and Scale-up Consultant with Expertise in Water Purification, Specialty and Commodity Chemicals. Membranes, and Advanced CompositesSummary Product development,and commercialization with specific focus to: Water purification, ion exchange, advanced composites, and specialty-commodity chemicals. formulated products (floor finishes, hard surface cleaners, boiler-cooling tower water treatments, food sanitization). Chemical Engineering scale-up, product and product development, commercialization, and process trouble-shooting. PVDF and PTFE membrane filtration and filters. Use of low energy electrical plasmas to achie...

Analysis of Soft Materials Expert Witness Reports and Mechanical Characterization of Soft Matter - Ph.D., Medical Device Expert Experienced researcher with a demonstrated history of project management in academic and industrial settings. Excellent communication and presentation skills in chemistry, materials science, data analysis, and polymers. Measurement of tensile and compressive properties of biomedical polymers and metals. Expert Witness Experience  Aided in characterization and compilation of results for hernia mesh litigation. Prepared data for thesis advisor to serve as expert witness in this litigation.

Business & Academic Environments- Production & Operational Teams, Building B2B Industrial Companies in Plastics, Life Sciences Industries, and ISO 9001 AuditorSummary  Chief Technologist with the successful execution of production and operational teams in business and academic environments. Developed materials and products for B2B industrial companies, in plastics and life sciences industries. Deploying over 15 years of experience in processing plastics, chemicals, and downstream products including films and medical devices.  Author, composing and presenting, scientific papers, grant applications, Patent Inventor, and patent b...

OTD/Occupational Therapy and Psychiatric Industry Writing and Author, including the Legal SectorRegulatory Medical Writing Clinical Medical Writing Editing Quality Control Business Development Expert Witness Experience Writing Experience (Phases 1, 2, 3, and 4): Wrote and edited ICH-compliant documents, including investigator brochures (IBs); Investigational New Drug (IND) applications. Marketing Authorization Application (MAA); informed consent documents (ICF); protocols and amendments. Clinical trial agreements (CTAs); clinical study reports (CSRs). Clinical evaluation reports (CERs); biologics license applications (BLA);...

Leader in Operations Development; Preclinical and Clinical Programs with an Integrated Strategic Approach Based on Combined Industry Experience Oncology Clinical Operations, Science, and Strategy ConsOncology and neuroscience program management, including preclinical and clinical development for novel therapeutics. Extensive work in the biotech and pharmaceutical landscapes including key industry trends, customer relations, and competitive landscape. Data-driven analytics and portfolio insights. Early- and late-stage clinical trial management. Site feasibility and startup procedures. Contract and budget review and negotiations. SO...