Pharmaceutical consulting / contracting company supporting Quality, Compliance, Analytical Methods and Novel Product Development. Specialization: Audit / Gap Assessment, Remediation, Validations, Methods Development, Dissolution Science, Polymer Characterization and Training. Providing project management and individualized support, specializing in FDA readiness, quality, compliance, investigations, remediation, methods and validation. Internationally recognized scientist and speaker known for drug delivery product and instrumentation development, dissolution science, and methods. Developed novel FDA approved controlled release products in addition to novel instrumentation to measure product performance. Expertise highlights include:• Quality Systems (Audit, Remediation, Investigation)• Analytical method development and validation• Separations and spectroscopic sciences• Dissolution science, kinetics, mechanisms, IVIVR/C• Chemical, polymer and materials characterization• Product development • Automation and instrumental design• Individual and group training

Project Manager, Continuous Product Release - validation of continuous real-time product testing. (Janssen Pharmaceutical Companies of Johnson and Johnson)

Project Manager, Polymer Characterization - to support the development and production of specialty pharmaceutical polymers. Establishing validated analytical methodologies, techniques, practices and software that aid in the development of unique custom pharmaceutical polymeric excipients that meet critical structural-property requirements and regulatory compliance. Responsible for training and leading a team to support the analytical and polymer characterization efforts of a specialty polymer development and production group. (Evonik Industries)

Prepare and present / Instruct webinars covering various topics on pharmaceutical regulatory compliance: Analytical Instrumental Qualification; GLP, Internal Auditing (ISO 19011:2011); Test Method Validation; and various other regulatory compliance issues.

Consultant – Product Development, Regulatory Compliance, Analytical Method Development / Validation (Alere, Inc, San Diego, CA; Epocal Inc., Ottawa, Canada; now Abbott Laboratories)Consulting in research, method development, validation, quality and regulatory compliance.• Regulatory Compliance – Audits / Data Analysis / Compliance Documentation• Analytical / Bioanalytical - Test Method Development / Implementation / Training• Analytical Instrument – Selection / Preparation / Installation / Training / Qualification• Research – Strategy / Product Development / Problem Solving / Remediation• Quality Control - Program Design & Implementation / Stability / SOPs / Personnel Training• Program Management – Strategic / Project Direction / Personnel / External Resourcing• Validation - Test Method; Cleaning; Software

Director / Research & Development New product research and development involving complex time-release and bioavailability profiles. Managed department, scientists and timelines. Developed drug delivery models, strategies, analytical tools, processes, products and process patent strategies.• New product developed from concept and submitted to FDA within two years (ANDA).• Produced two successful products passing human clinical studies in one year.• Two additional products in Pipeline, involving different APIs and delivery systems.• Developed highly efficient and cost effective product manufacturing processes.• Designed novel product development strategies for multiple products.• Designed / collaborated animal and human clinical studies.• Directed analytical method development, experimental design and data analysis.• Recruited, trained and developed a successful product development group. Director / Quality Control, Method DevelopmentDeveloped and directed a new pharmaceutical Quality Control department. Managed chemists, priorities, resources, contract labs and timelines in support of raw material, in-process, finished product and stability testing. Developed analytical testing and data processing methods, along with instrumental and software quality systems.• Directed Quality Control group (chemistry and microbiology)• Performed internal audits and established needed pharmaceutical quality systems.• Recruited, trained and managed new chemists.• New chemical methods developed / validated: raw material, in-process, finished, stability.• Created / upgraded QC SOPs, protocols, studies, reports and compliance documents.• Established instrument and software qualification / validation systems (IQ/OQ/PQ).• Stability Program and data analysis for CMC submission.• Expanded QC to meet needs of successful new products.

Course creation and instruction on Dissolution Testing.

• Managed pharmaceutical research group that developed analytical chemistry methods, performed analyses and conducted pharmaceutical and physical organic chemistry research in support of new drug delivery and pharmacutical products.• Developed new analytical technologies, including fully automated instrumentation that supported and expeditated product approvials.• Published, presented, chaired conferences internationally; created and taught a dissolution technology course.• Headed up interdepartmental special and validation projects, along with international collaboration efforts.• Maintained regulatory compliance for laboratory, analytical methods, software, technology and product development, and in support of product submissions.