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,...

Drug Therapeutic Discovery Medicinal Chemist Consultant: Pain, Inflammation, Cardiometabolic, Oncology and AntimicrobialsHit generation, lead identification, and lead optimization. Strategies, implementation plans and problem solving.Drug Discovery - "Concept to Clinic" - Road map and expectations. Goal setting, testing schemes, progression path tracking.Intellectual Property - Assessment, strategies and management. Due diligence on prior art, patentability. Expert witnessDrug discovery across therapeutic areas - Pain, inflammation, cardiovascular, metabolic, oncology and antimicrobial therapeutics.PK/PD (Pharmacokinetic and Pharmacodynam...

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...

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...

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...

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...

Pharmaceutical Regulatory Consultant with Broad SNDA, GMP, API Development Experience.Development of commercial manufacturing, FDA and international registration and approval for atracurium besylate, trifluoridine, bupropion hydrochloride, zidovudine, exosurf, mivacurium chloride, doxacurium chloride, pseudoephedrine hydrochloride, acrivastine, valciclovir, tramadol hydrochloride, topiramate, levofloxacin, surfaxin, vinorelbine tartrate and lamotrigine.Major process SNDAs for ofloxacin and leucovorin calcium.Regulatory documentation and approvals (FDA request for NDAs for grandfathered products) for digoxin, melphalan, azathioprine, thiogu...

Consultant with Diverse Pharmaceutical Experience in Formulation Development, Manufacturing, Technology and Site Transfer, Process Design, Scale-Up, and ValidationPharmaceutical formulation development, manufacturing technology transfer, site transfer, process design optimization, and scale-up for domestic and international clients.Product development using QbD approach, process scale-up and optimization, process validation.Drive technology platforms such as solid and Liquid orals, aseptic filling, softgels, orally disintegrating granules, powders, MR products, X-ray contrast media, peptide injectable product, topicals, steroids and hormo...