Specialties: New Product Commercialization, Biologic/Conjugate/ Therapeutic Protein Process Development and Validation, CTA, & MAA CMC authorship. Strong knowledge of International Regulatory Filing, requirements in EU and Emerging Markets, International Drug Safety and Risk Management, Supplier Qualification Auditing, Process Equipment and Cleaning validation, Automation validation, DP production; small molecule and biologics. Regulatory preclinical & clinical planning and project management. Single Use Technology (SUT) DS/DP platform development / implementation, SUT supplier selection / qualification / monitoring, and technology transfer for clinical and commercial biopharmaceutical...
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