Head Of Downstream Process Development
CurrentFocus: Development of robust, cost effective, scalable downstream bio-processes and technology transfer. • Managing and supervising teams of scientists, engineers and technical staff focused on developing novel, efficient, scalable and transferable downstream processing and technologies to manufacturing facilities for both for Government and commercial clients. • Expertise in downstream operations including harvest, clarification, chromatography, filtration, viral clearance, formulations, optimization, risk assessments and mitigation, strategic planning, budgeting etc.• Experience in scale-down model validation and process characterization studies towards product development for commercialization. Drafting and review of tech reports and regulatory documents.• Cross functional management/collaborations with upstream, analytical, QC, QA, cGMP, vendors, project management, regulatory agencies, and clients for timely execution and delivery of bioprocesses. • Demonstrated history of successful development and delivery on multiple projects involving recombinant proteins, antibodies and in particular challenging viral vectors such as Vaccinia, Chikungunya, Zika, Ebola, Dengue, YFV, VLPs, Polio, HCMV, HIV, Myxo, AAVs etc.