Oncology Therapeutics, RNA/DNA Isolation-Purification, PCR-Cloning and Mutagenesis, In Vitro Transcription (IVT), In Vitro Diagnostic and Antibody Production.Biotechnology/Nanotechnology Industry Expert - Oncology Therapeutics, RNA/DNA Isolation-Purification, PCR-Cloning and Mutagenesis, In Vitro Transcription (IVT), In Vitro Diagnostic and Antibody Production. Endogenous Biomarker Characterization, Aptamer and Nucleic Acid Technology DevelopmentPharmaceutical and Biotechnology drug discovery, diagnostic research and development, business development.Identify and implement technologies in strategically relevant areas to maximize value...

Biopharmaceutical Industry Consultant - Computational Technology, Therapeutic Areas; Immunology, Oncology Delivering Clinical Candidates, Structural Biology and Medicinal Chemistry.Biopharmaceutical industry leader-small molecule and antibody drug discovery.Structural biology and medicinal chemistry.Broad knowledge base- hands-on; advanced computer simulations and biology, create, lead projects, identify unseen opportunities. Internal and external collaborative projects.Analysis-evaluation for Pharmaceutical licensing opportunities.Pharmaceutical due diligence, target-technology assessment.Align drug discovery and technology validation eff...

Ph.D. Personal Care and Cosmetic Product Launch, Regulations, Safe Polymers and Polymer Additives, Skin Care, Sun Care, Make-Up and Hair Care Formulation Expert.Research and development of cosmetic and personal care products and ingredients.Research and development of natural products and extracts.Analytical method development (HPLC, HPTLC, UV-Vis, NMR, FT-IR, DSC, TGA).Skin care, sun care, make-up and hair care formulation.UV filter recrystallization.Sensory panels, physical-chemical and rheological assessment.Intellectual property documentation.Cosmetic science and technology trainings.Technical training and support to sales personnel.Fu...

Ph.D. Organic Chemistry Consultant with Expertise in Drug Discovery and Early Development in Pharma and Biotech Industries. Infectious Diseases, Immunology, Oncology, CNS and Metabolic Diseases.Drug Discovery and Development Leader in the pharmaceutical and biotechnical Industries.Deliver candidates into clinical development with focus on infectious diseases, immunology, oncology, CNS and metabolic diseases.Raising venture capital and non-dilutive funding.CRO and CMO landscape Program Manager, setting up partnerships and collaborations.Execute complex research programs in a virtual environment.Project management, timelines and budgeting.Me...

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...

Ph.D Scientist with Expertise in MRI Imaging, Pharmaceutical Biomarkers, In-Vivo Imaging and Medical Device ExpertSummaryDeveloping imaging biomarkers for the pharmaceutical and medical device industries.Biomedical imaging and computer sciences.Magnetic Resonance Imaging (MRI) data acquisition and data analysis, image and signal processing techniques, numerical methods, multicompartmental models and linear systems.Development and validation of quantitative imaging (MRI) biomarkers.Project management and study design of scientific (R&D) projects.Site training and implementation of in-vivo imaging studies.Quality control and analysis of imag...

Global Ph.D. Biopharmaceutical Analyst Expert: Lean Manufacturing, Program Management, Validation and QualificationCreating lean analytical departments with significantly improved efficiency and turn-around-times. Organizational effectiveness and culture improvementStrategy and execution for concurrent large-scale projects.Biologics (large molecules); small molecule development and analytical development.Research and development executive management; project program management and validation and qualification.CAPA; investigations; drug product development and transformational leadership.CMC expertise: IND, BLA, NDA, 510K, PMA, ANDA, qu...

Regulatory Pharmaceutical Compliance Consultant with Expertise in Clinical, Pharmacovigilance, Biologics, Biosimilars, Orphan Drug, Medical Device, Natural Health Product, Dietary Supplement, Cosmetic, and Food.Regulatory strategy, pathways and gap analyses.Regulatory submissions and applications for diverse product types to global regulatory agencies: Health Canada, US FDA and EU EMA (CTA, IND, IDE, DMF, NDS, SNDS, ANDS, SANDS, DIN, NDA, NDA 505(b)(2), BLA, ANDA, PAS, CBE, CBE-30, 510(k), PMA, HUD, HDE, Class II, III and IV Device License Applications, ITA, MAA, Type I and II variations, Technical File, PLA, Amendments, Notifications, a...

Pharmaceutical Development Expert: Planning, Portfolio, Technical Analysis and LicensingPharmaceutical and biotechnology business development and new product planning.In and Out licensing and strategic partnering.Commercial analysis and forecasting.Pharmaceutical life cycle management.Start-up of Pharmaceuticals, business building in proprietary, generic, and OTC pharmaceuticals and biotechnology, providing modeling and commercial assessments.Undisclosed Company, Chief Consultant, 2014 - PresentPrepared for pharmaceutical start-up forecast models and...

Designing, Commissioning, Qualification and Validation in the Pharmaceutical IndustryPharmaceutical standards regulations: BPF, BPL, GMP, Europ%uFFFFe Pharmacop%uFFFF and FDA 21CFR part.11.Quality assurance and the standards regulations requirements for the pharmaceutical industry.MethodologyRisk Analysis (AMDEC, HACCP)Six SigmaTechnical ExecutionPharmaceutical quality assurance and the standards regulations requirements.Design, quality, commissioning and qualification documentation of pharmaceutical processes.FAT, (Factory Acceptance Testing),SAT, (Site Acceptance Testing) commissioning, (re)qualification and validation tests.Aseptic pro...