Pharmaceutical R & D consultant specializing in strategic and operational planning, safety assessment, toxicity study protocols and re-engineering.Pharmaceutical research and development methodology.Pharmaceutical research and development portfolio strategy and management.Drug development modeling, scenarios and matrices for decision support.Re-engineering and R&D core business systems; R&D budget and resource forecasting.Pharmacoeconomics, health outcomes and disease management.New Chemical Entities (NCE) drug development.Phase I to Phase IV drug pre-clinical and clinical safety assessments.Pharmaceutical IND, NDA and ANDA registrations....

Pharmaceutical Consultant Specializing in Drug Dissolution, Liquefaction, Laboratory Management and Regulatory ComplianceDissolution (reduction to a liquid form; liquefaction) method development, validation, transfer and troubleshooting.HPLC method development, validation and transfer.Laboratory instrument qualification and calibration.GMPs/ICH/USP: laboratory Quality Assurance and regulatory inspection readiness.Regulatory specification development.Preparation of the CMC (Chemistry, Manufacturing and Controls) section of IND (Investigational New Drug) and eCTD (Electronic Common Technical Document).Development of SOPs and Quality System...

Dosage From Pharmaceutical Consultant: Facilities Management and GMP ComplianceFormulation and process development of multiple types of pharmaceutical dosage forms.Research and development, optimization, manufacturing and packaging of solid, liquid and powdered dosage forms.Scale up and technology transfer of multiple dosage forms.Equipment and processing knowledge, product processing/equipment trouble-shooting and facility validation and qualification activities.Identifying and implementing significant operational cost savings in pharmaceutical operations.Auditing of diverse cGXP operations (API manufacture, laboratory operations, clinica...

Drug Analytical Support Consultant with CMC and Consent Decree ExpertiseAssessing specification and CMC analytical development for pharmaceutical drug substances and drug products.Analytical project planning and strategies for early, mid and late stage development programs.Writing, editing, and reviewing analytical technical reports.CMC and regulatory submission documents for Health Authority and FDA responses.HPLC method development, validation and transfer.Subject matter expert for the isolation and identification of synthetic impurities and degradation product unknowns.Contract Research Organization (CRO) management.Analytical Investiga...

Drug Stability and Drug Quality Consultant and Analytical ChemistProduct experience includes brand, generic and drug substance (active pharmaceutical ingredient, API); small molecules, biologics, vaccines; Rx and OTC products; oral, topical, and parenteral dosage forms.Pharmaceutical compliance and remediation, quality systems management, data integrity audits, product quality assessments, gap assessments, batch reviews, laboratory and manufacturing oversight.Authoring of policies, procedures, training programs. Technical and business writing, editing, and proofreading: Proposals, quality agreements, standard operating procedures (SOPs), p...

Pharmaceutical Quality Auditor: Excipient GMP auditing, International IPEA, and ISO standards, 9001, 17025, 14065Certified Quality Auditor with 20 years experience of working with quality systems.Trained in a number of ISO standards, Pharmaceutical Excipient GMP auditing and is an approved auditor for International Pharmaceutical Excipients Auditing (IPEA).Experienced with ISO 9001, ISO 17025, ISO 14065 and Lexcel, Law Society's practice management standard.Undisclosed Company, Director, 2008 - PresentA consulting firm servici...

Consultant for Biopharmaceutical Process Development, Operations and cGMP CertificationOver thirteen years in the life science industry with more than ten years of downstream process development, technology transfer and cGMP experience for combined biopharmaceutical, in vitro diagnostics and medical device industry.In depth experience in finding and implementing practical solutions to both midstream and downstream processes.Four years of hands on experience working in the clean room environment, witnessing and troubleshooting the processes, data analysis and quality oversight within a highly regulated cGMP manufacturing environment.Four ye...

GMP Biochemistry Consultant and Laboratory Manager in CanadaOver fourteen years in the Canadian life science industry specifically in biopharmaceutical GMP development and manufacturing.Directed major operational departments including quality assurance, quality control, validation, operations, process development and project management.For start-up company established operational departments, internal business systems, annual budgeting, personnel management and mentoring, contract estimation, contract negotiation, contract management and quality oversight, all within the highly regulated GMP manufacturing environment.CMC commercial portfo...

Industrial chemist with extensive experience in Medicinal Chemistry, Drug Discovery, Organic Synthesis, Technical Writing, cGMP, Chemical Hygiene and Lab Safety, and EPA & OSHA ComplianceMedicinal chemistry, process research and development, and organic synthesis.Drug discovery, including small molecule structure-based design and SAR optimization in collaboration with CADD, biology, ADMET, and informatics teams.Design and synthesis of complex organic compounds for medicinal applications.Rational, structure-based drug design and development.Design and execution of optimized, scalable, safe chemical processes for drug intermediates and APIs...

Drug Quality and Compliance Expert in Analytical Chemistry, Drug Stability, Out of Specification Investigation, Manufacturing Change Control and cGMPSummaryPharmaceutical quality and compliance, analytical method development and validation.Interpretation of changing regulations.Thirteen years of pharmaceutical industry experience operating within both GLP (Good Laboratory Practices) and GMP (Good Manufacturing Practices) environments that included eight years of pharmaceutical research and development, hands on technical and research experience, in analytical method development, validation, and application and five years of technical and...