Drug product lead for late stage parenteral products. Sterile drug product development and manufacturing SME. Lyophilization, ADCs, Biologics, Small Molecules, CMC, and Tech Transfer.

Drug product lead accountable for regulatory submission and commercial launch readiness activities. Strategic contributor and lead drug product author for global marketing authorization application.

Drug product lead for late-stage innovative sterile injectable. Led formulation and process development, optimization, and scale-up. Drove technology transfer activities for engineering and ICH stability batch manufacture.

Led lyophilization process development, optimization, scale-up, and transfer to enable manufacture of clinical supplies for Phase 3 investigational product in less than 6 months. Responsibilities included coordination with receiving site regarding process design, control strategy, batch record authoring, and continuous process improvements.

Developed broad range of skills through cross-functional rotations in Analytical Research Development, Marketed Product Support, Portfolio and Program Management, and Formulation Development.

Conducted preformulation studies on aerosol, oral, topical, and solid drug products. Advanced characterization and understanding of pharmaceuticals with regard to dissolution/absorption, physical/chemical stability. Supervised the testing of novel meterd dose inhalers.

Assisted with project aims focused on the investigation of transcription factors and their role in cell metastasis. Tasks included human tissue culture, adeno virus amplification and purity, bacterial transformation, DNA sub-cloning, PCR, western blotting, RNA and protein collection.