SUMMARY Chemistry, Manufacturing and Quality Control * Strategic Development of small molecules, proteins, peptides, oligonucleotides, medical devices, OTC, generics, nutraceuticals and supplements * Manufacturing site evaluations, scale up for registration/validation API, Drug Product and Biologics * GLP, GMP, GLP, ISO 9000 and/or ISO 13485 of US and International contract manufacturing and laboratories - All subsequently FDA approved sites * Successful orchestration and development of multiple client manufacturing Sites (5 International) for Drug Substance/Drug Product managed through product launch and commercial manufacturing * Scale up and process development for products including fill and finish * Quality by Design development of multiple products from small biotech to large pharma * Experience in Analytical chemistry, biochemistry, immunology, cell biology, molecular virology and all applicable techniques * Designed Quality Systems and written supporting documents (SOPs) etc. Regulatory Submissions * Project lead for the resurrection of previously submitted submissions for approval for all 5 modules of eCTD * Post Marketing CMC support including submissions supplements, annual reports, FARs, compliance and regulatory authority reviews and all document reviews. * CMC Consent Decree Support and Mitigation - review and gap analysis for international submissions, recalls, compliance, CAPAs, strategic planning, risk mitigation, etc. * 2 PMAs 8 510K's, 2 IDEs, OTC Registrations prepared/submitted - All filed, approved * 8 NDAs (1 Orphan Drug)/CTDs 2 ANDAs, 5 BLAs, 17 INDs, prepared/submitted and All filed approved * Author of clinical, preclinical and CMC submissions for multiple registration authorities * Speaker and regulatory trainer - Drug Information Association (DIA -eCTD) * Sponsor's representative for various government meetings including FDA, Advisory Committee meetings, Schedule A, B and C in addition to BARDA, DOD, EPA and NIH * Publication of electronic and paper filings including orphan drug submission * Project Manager for the development, review and approval process for all pre-commercials to commercial products. * Understanding of EU regulations and blue box (packaging) implementation Project Management * Managed Clinical Operations for 10 Phase 1 through Phase 3 clinical studies * International product investigation and recall managed successfully resulting in product improvement, company acquisition and increased sales * CRO management * Interim VP of Project Management, Regulatory and Quality Assurance for an international (China) anti-bioterrorism project-successfully initiating preclinical monkey supportive care studies including hands-on training to support significant BARDA and DOD contracts * Managed research and development teams for biologics, pharmaceuticals, vaccines and submissions

Highlights:

• Risk Assessment
• Support
• Systems Development
• Acquisitions
• Dermatology
• Diagnostics
• Imaging
• Marketing Management
• Marketing Support
• OTC