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...

Protein engineering and protein evolution related to drug resistance and molecular toxicologyRandom mutant library generation.Protein engineering.Mutagenicity assays, (Ames' test).ColE1-based plasmid regulation.DNA repair, specifically repair of reactive DNA methylation.Drug resistance: targets, evolution.Microbial genetics.Molecular pharmacology.Molecular toxicology.Undisclosed University, Assistant Professor, 2007 - PresentHead of a research team including a senior scientist, technician, graduate student and several undergraduate assistants.Obtai...

Expert and professor on environmental toxicity, teratology, developmental biology, human embryology and reproductives physiology.Environmental toxicity and developmental toxicology (teratology).Toxicology, teratology (reproductive toxicology), reproductive physiology, environmental medicine, and endocrinology.Taught courses on teratology, developmental toxicology, both general and environmental toxicology, developmental biology, human embryology, reproductive physiology, endocrinology, general physiology, and technical methods.Current research interests include investigation of mechanisms and development of assays for developmental toxici...

Pharmaceutical Drug Development Expert: Scale-up, Technology Transfer, Process Optimization, Troubleshooting, Clinical Supplies, FDA and ICH Quality and ComplianceManaging pharmaceutical operations, process and analytical methods development.New pharmaceutical product formulation development, scale-up, process start-up, optimization and troubleshooting.FDA-recognized expert in formulation development and technology transfer.Pharmaceutical licensing, Regulatory Affairs (CMC), quality systems and staff management.

Consultant for Pre FDA Quality Audits for Medical DevicesMedical Device quality assurance and regulatory compliance professional possessing over 28 years' experience.Manufacturing, pharmaceutical, biologic, and medical device operations.21 years of employment with the FDA, primarily as a Medical Device Investigator.Professional consulting; FDA Medical Device Quality regulations and FDA compliance.ASQ certified, (QBA) medical device regulatory compliance and non-technical quality assurance expert, specializing in medical device quality systems.Failure modes and effects analysis of medical devices.Metallurgical engineering technology as appl...

Pharmaceutical Regulatory Strategy Assessment, Development and Execution for Novel Therapeutics, Interactions with Regulatory Authorities and Regulatory Due DiligenceStrategic regulatory aspects of the development of novel therapeutics encompassing initial registration - approval and life-cycle management of multiple pharmaceuticals (in multiple therapeutic areas).Planning and execution of interactions with regulatory authorities (esp. US FDA).Regulatory due diligence review and appraisal of therapeutic development programs, regulatory aspects in the development of a pharmaceutical for the legal defense.Regulatory due diligence input on po...

Medical Device Risk Management, Quality Systems Management, Supplier Qualification and Quality Assurance: In Vitro Diagnostic Medical Devices (Class II), Biotech Manufacturing Operations, Digital Imaging Equipment, and Interventional Devices (Class III), Bio-based MaterialsMedical device and biomedical industry planning, Integration, and organizational improvements, increasing financial performances for U.S. and European businesses.Aligning technology and business strategy, medical device quality management regulations and requirements into effective and useful management systems.Remedial quality management system compliance.Pre-certifica...

Experienced Senior Scientist Obtains Proven Track Record in Research and Product Development, Support, Validation. Clinical Assay Development, Medical Devices, Planning- Executing 510(k) Applications.Summary Experienced Senior Scientist with a proven track record in research and product development/ support/ validation. Clinical Chemistry Expert; polymer chemistry, assay development, medical devices, fluorescence, planning and executing 510(k) studies, writing and editing 510(k) applications. Subject matter expert for chemistry and test method validation on behalf of clients’ companies. Numerous processes validation during compli...

Regulatory Affairs Consultant for Medical Devices: Expert in U.S. and Canadian Medical Device Approval ProcessSummaryTwenty plus years working in the medical industry in the areas of regulatory affairs, quality assurance, clinical studies, research and development, test, manufacturing and technical service.Regulatory affairs consultant servicing worldwide providing clients with compliance, submissions and training services to the medical device and IVD Industries.Regulatory ExperienceExpert knowledge of U.S. FDA, Health Canada and the European Medical Devices Directive regulations.Product approval and clearance submissions such as 510(k)s...

Software Validation and Quality Consultant for FDA ComplianceAuditing for ISO 13485, FDA QSR, ISO 9001, MDD and IVD, CE mark.Specialist on FDA regulated industries and software validation requirments.Process validation, software validation, Part 11, GMP development, ISO 13485 development.FDA response and remedial actions, quality systems creation, quality systems improvement.Creation of technical course and leading training groups on FDA-QSR and Software Quality, including training effectiveness assessments.FDA quality documentation, risk management, specification development and sampling plan analysis and rationale.