Pharmaceutical Quality Assurance Quality Control expert with experience with U.S., E.U., Canada, and India regulationsPharmaceutical Quality Assurance and Regulatory Affairs.Compliance audit, Quality Operations and Regulatory Submissions.Design and implementation of Quality Systems and regulatory compliance programs.Domestic and international quality and regulatory compliance.Managing contract / vendor supply chain quality programs.Developing and delivering GMP, GDP, DI procedure training programs.Leading the Quality efforts to successfully remediate recurring failures.Generation, maintenance and revision of SOP's, specifications, procedur...

Biomedical-Bioanalytical Nanotechnologist Expert with Experience in Medical Device, Aerospace, and Military-DefenseBiomedical nanotechnology.Bioanalytical nanotechnology.Nano science and technology.Nano fabrication and characterization.Technological entrepreneurship.Nanotechnology energy and sustainability.Medical device development.Design controls.Electrochemistry.Energy and renewable energy.Business plan formation, strategic innovation, and marketing for the nontechnology industry.Nanotechnology energy and sustainability.Translate complex operations and theories of innovative emerging technologies in the biomedical and bioanalytical nano...

Ph.D. Biochemist with expertise in Protein Engineering, Purification, Characterization, Molecular Biology; PCR, Mutagenesis and CloningMolecular biology techniques; PCR, mutagenesis and cloning.Expression of heterologous proteins in variety of organisms such as bacteria, yeast, insect and mammalian cells.Protein expression analysis using High-Throughput Screening.Evaluation of protein expression for solubility, stability and scalability using numerous tags (example: His-tag, MBP-tag, Halo-tag etc.).Method development and implementation (microgram to gram quantities) of protein purification processes from recombinant sources using almost al...

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...

Borosilicate Pharmaceutical (Type I Glass Containers), Syringe Formats, Vials, Cartridges, Ampules, Injectors and Injector Systems ConsultantBorosilicate pharmaceutical (technical support for Type I glass containers Borosilicate glass-neutral glass) expert for parenteral packaging as well as barrier film expertise for the packaging of sensitive solid dose drugs.Inorganic glass material for pharmaceutical sectors (mostly silicates) or mixture of materials when heated up then cooled, solidifying without crystallization.Technical review of Type I glass suitable for packaging material in most preparations whether parenteral or non-parenteral,...

Transitional Medicine-Protein Therapeutics and Nanobiotechnology Focusing Alzheimer’s, Brain Trauma & Cancer Through Drug Development, Nanoparticle based targeted-drug delivery of chemotherapeutics an  Recombinant antibodies (scFv, Fab), immunotoxins and antibody-drug conjugates (ADC), targeting characterization and pre-clinical testing in animal models. Expression, purification and characterization of biotherapeutics and testing in cancer xenografts in mice. Combinatorial phage library screening in disease models of cancer, brain diseases (Alzheimer’s, Traumatic Brain Injury) and drug-resistant bacterial infections. Transit...

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...

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. Cosmetic and Personal Care Consultant with Expertise in Bio-Active Complexes for Formulation, Claim Substantiation, Active Ingredients, INCI Regulations, Skin Care, and Hair CareIdentifying and developing innovative biologically active raw materials leading to the formulation of successful skin care and topical dermatological OTC products.Development of formulations by designing the bio-active ingredient combinations.Help oversee In vitro and In vivo activity testing.Develop product claims and claim substantiation.Work with marketing and public relations to communicate technology to the press and consumers.Knowledge of labeling regu...

Dental and Technology Industry Consultant: Dental Devices, Laser, Intellectual Property, Medical Malpractice, Patent Infringements, Prior Art, and FDA WorkMedical laser technology and product development with specific focus to the Medical Infectious Disease and Dental Surgical industry.Bacterial and fungal elimination laser system.Photobiology technology in the medical and dental industry.FDA Approvals (FDA 510(k). Products: Lumenis, Contact Bone Ablation with Er:YAG lasers and OPUSDUO; OPUSDUO E; OPUSDUO EC, OPUS 20; and OPUS SPECTRUM.FDA cleared and CE Mark approved Onychomycosis Laser System selling world-wide.Dual Wavelength Infrared...