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• Provide strategic, operational, procurement, quality, regulatory, and CMC, talent development and leadership mentoring in the fields of Biotechnology, Pharmaceutical R&D, Analytical Testing & Clinical Trials from early-, mid-, and late-stage of clinical development through to commercial licensure of biologics, and drugs including monoclonal antibodies, fusion antibody proteins, recombinant human coagulation factors, cytokines, growth factors, therapeutics, vaccines, cell and gene therapy products._x000D_ • Subject Matter Expertise in arenas of biologics, vaccines, cell and gene therapy: process development, scale up, global technology transfers, facility DQ, IQ, OQ, PQ, validation & start up, commercialization, drug launches, and large-scale CGMP manufacturing from clinical through to commercial manufacturing & distribution, quality & compliance, analytical testing strategy, regulatory submissions and inspections with world-wide health authorities and regulatory agencies.
| Type | State | Agency | Certificate # |
|---|---|---|---|
| WOSB | National | Small Business Administration (SBA) | — |
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