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...

Scientific Engineering Consultant Specializing in Device and Instrument Development, Method Optimization in Bioanalytical, Microfluidic, and Nanotechnology ApplicationsDesign of microfluidic devices and instrumentation for analytical and forensic analysis.Development of biological sensor and methods for protein and DNA detection.Development of miniaturized methods for processing of biological samples.Integration of novel technologies to new applications and processes.Scientific writing for grant proposals and other scientific publications.

Disruptive tech designs need solid foundations. Physics and math provide required seminal tools. Existing materials/devices, how do they figure in present tech scenario? We search in this realm. Researcher and professor with 25+ years of experience executing math-physics inspired solutions to bridge the gap between academy and industry. Involved in projects encouraged to develop models and implement numerical solutions for technological demands, present and predicted ones. Solutions offered always enclosed by European Union regulatory requirements. Upon proof of concepts designs, main areas where effective solutions are being provided are...

Expert in Formulation Development, Design, Characterization, Capital Equipment Selection, and Processing of Powder Based Materials, with Associated Analytical SciencesTheory, design, applications and practice of Spray drying and powder technologies of forty years in the following areas:Formulation development, design, characterization and processing of powder based materials, with associated engineering and analytical sciences.Equipment design and fabrication, component specification, vendor selection, and procurementProcess design, instrumentation and control.Equipment manufacturing design and delivery of spray dryers and other capital eq...

Ph.D Pharmaceutical Regulatory and Laboratory Compliance, Quality Assurance and Controls (cGMP, FDA, ICH, EMA, ISO) ConsultantPharmaceutical and biotechnology product development, management of cGMP compliance quality systems, quality control, quality assurance, (in unique dosage forms, and sterile-nonsterile processing methods).Laboratory quality systems for both pharmaceutical development and quality control testing.Complete laboratory outfitting including qualification and method implementation.Test method development, transfer and validation.Analytical measurement and techniques.Auditing systems and processes.Analysis of APIs, raw mate...

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...

Design and Synthesize Drug Candidates for Discovery and Development: Chiral, Polycyclic, 3-8 Step Synthesis for Cancer, CNS, Pain, Diabetes, Microbial Infection, AIDS). Design and Synthesize Diagnostic Reagents and In Vivo Imaging Agents - Macrocycles, Antigens, Polycyclic Heterocycles.Synthetic and discovery organic chemistry for the pharmaceutical industries with applications in CNS, cancer, and pain.Preclinical development chemistry for pharmaceutical scale-up, metabolites, impurities, and deuterated drug candidates.Synthetic organic chemistry for in-vitro and in vivo diagnostics, including antigens and biotin conjugates with varied r...