Vice President of Quality
| Pharmaceutics International, Inc
Accomplished professional with over 20 Years’ Experience in Pharmaceutical/Biotechnology industry. Leadership in Quality Assurance (APIs, Drug Products, Excipients), Quality Control, Regulatory Affairs, and Phase Specific GMP (US, EU), Background in Validation, Technology Transfer and R&D. In-depth scientific and technical knowledge of Analytical and Organic Chemistry. Experience in Biologics as well as small molecules. Strong background in Organic Synthesis, Strong managerial, supervisory, and mentoring skills. Documented record of accomplishments Experienced Synthetic Organic Chemist/Process Chemist/Medicinal Chemist. Over 25 years’ experience in developing Multi-Step Synthetic Pathways, Isolation and Characterization of complex Organic Molecules, Pathway Selection, Process Improvement, Medicinal Chemistry, Protein and Peptide Chemistry, Drug Discovery and Troubleshooting. Experienced in Multi-Site and Multidisciplinary Project Management and Resource Allocation (Time, Budget, Equipment). Expertise in cGMP Compliance (FDA/ICH), Technology Assessment, Technology Transfer, GMP-Audits, CRO/CMO qualification, Negotiation, and Outsourcing. Strengths include Organization, Communication, Mentoring, Team Building, Staffing, Training, Facilitating, Procurement and Consulting. Also experienced in Quality Assurance. Documented Record of accomplishments backed by Patents, Publications, Honors and Awards
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