Pharmaceutical API and QA Consultant with Expertise in Steroids and Norsteroids Manufacturing. Lean Management, Validation, FDA InspectionsActive Pharmaceutical Ingredient (API) manufacturing and quality assurance, successful scale-up, technology transfer and quality assurance projects.Steroid plant operations; training, FDA inspections, and manufacturing.Lean management in API manufacturing.Quality assurance management; release operations in packaging processesAPI manufacturing - steroids and norsteroids.Pharmaceutical products scale-ups and technology transfers.Qualification of equipment (reactors, centrifuge, dryers etc.) and utilities,...

PhD Biostatistician with expertise in Regulatory (FAD and EMA activity), Data - Safety Monitoring in the Pharmaceutical and Medical Device Industries. Scientific Advisory Participant.Biotechnology FDA and EMA submission in the pharmaceutical and medical device industries.Biostatical litigation specific to pharmaceutical and medical devices.Pre- and Nonclinical, Phases I - IV in biostatistics, data management, statistical programming, and etechnology across various therapeutic areas.Analysis of over 420 clinical studies, with over 30 in Integrated Summary of Safety and Integrated Summary of Efficacy (ISS/ISE).Build effective innovative an...

Intellectual Property and Regulatory Consultant Specializing in Patents on and FDA Regulation of Novel Medical Device and Biotech DevicesIntellectual property (IP) and regulatory strategy.FDA regulation of novel products such as wearable medical devices, and electronic cigarettes.Patent protection of drugs, medical devices, dietary supplements, and tobacco products.Patent landscaping and freedom-to-operate analyses.Consultation with and representation before U.S. Food and Drug Administration (FDA).IP and regulation surrounding novel technologies such as RNAi, gene editing, and synthetic biology.In vitro diagnostic medical device and consu...

Ph.D. Expert Developing Immunology and Molecular Assays, Due Diligence, Gene Editing, RNAi, Automated Cloning, CRO, CMO and IND SubmissionsAssessments and due diligence for funding of synthetic biology companies. Mentor to start-ups within the Biological portfolio to attain seed and series funding.Synthetic biology, specialty chemicals, and nutraceutical products.Develop and execute cell-based, immuno, and molecular assays for release of large molecule therapeutics.Development of assays for large molecule therapeutics from multiple modalities including monoclonal antibodies, antibody-drug conjugates (ADC), T-cell engagers, and small pept...

Specialty Chemicals & Pharmaceutical Supply Chain-Change Agent, Regulatory, EPA, OSHA-PSM and Global Manufacturing ExpertPharmaceutical and specialty chemical operations with 20 years’ in supply chain Leadership for large facilities, providing technical solutions in challenging environments in union and non-union members. Manufacturing and operations professional, action-oriented, building effective teams and delivering positive results with unlimited drive for continuous improvement in fast paced, global businesses. Change agent and transformative leader in global manufacturing footprints leading to increased efficiency and throughp...

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...

Pharmaceutical Certified Quality Auditor with Focus to: Document/Data in Quality Management System, cGMP, GLP, GCP, ICH, EP, USP, NF, DEA, SOPs and ProtocolsExperienced cGMP and ASQ Certified Quality Auditor (CQA) solving quality issues and improving quality systems. Document/Data auditor for Quality Management System, cGMP, GLP, GCP, ICH, EP, USP, NF, DEA, SOPs and protocols. FDA compliance in a pharmaceutical environment; FDA regulations including 21 CFR 11, 120, 210/211, and 820; plus, ISO 13485. Demonstrates proficiency in reviewing, editing, and writing SOPs, ensuring accuracy, clarity, and compliance with all applicable guideli...

Consultant for Pharmaceutical Marketing Research and Drug Program ManagementSenior consultant with 15 years of research experience in academic and industrial settings with a Ph.D. in Immunology.Marketing research of competitive assessment of pharmaceutical market segments and geographical regions.Pharmaceutical and biotechnology drug development, drug company portfolio analysis, strengths, weaknesses and opportunity assessment.Pharmaceutical and biotechnology drug and intellectual property valuation.Clinical trials, FDA filings, product lifecycle management and project management.Experience in collaborating with customers, at different le...

Plastic Compounding Consulting Expert with Twin-Screw Extrusion and Plastics Testing Laboratory and Underwriters Laboratories Experience and Significant Far East Experience30 years of plastics testing and consulting businesses with continuing Asian technical and business contacts. In-depth technical and operations knowledge of plastics processing and compounding. Formulations expert in polyethylene (PE), polypropylene (PP), polybutylene terephthalate (PBT), nylon, polycarbonate (PC) and alloys, acrylonitrile-butadiene-styrene (ABS) and other engineering resins. Process design and experience in single screw, twin screw and FMC compound...

Leading Product Creation Though CE/FDA Submission, ISO, MDSAP Audit, R&D Documents (DHF): DI, DO, Risk, V&V plan, Protocols and Reports. Quality Procedures Implantation, Quality & Regulatory BinderAssurance, Quality Control, and Regulatory Affairs Manage and establish total quality system according to EN ISO 13485:2016, MDD/MDR Requirements and QSR (21 CFR 820). CE ( European Certification) certificated from technical documentation preparation through submission and external audit by notified bodies. Other countries certificates: Japan (including on-site audit), Korea, Canada, Australia, India with special requirements of different...