Thomas Bednarz Email & Phone Number

• Develop manufacturing batch records to cGMP processes. • Monitor and support manufacturing processes real-time in the manufacturing facility.• Development for upstream technology transfer and manufacturing support. • Develop and implement tools to improve product recovery. • Work closely and effectively with upstream development, downstream development, manufacturing, quality assurance, and the analytical group. This facilitates upstream process development and technology transfer to the manufacturing site.• Establish schedules for day to day operations. • Technology transfer to internal sites and technical support of cGMP manufacturing of monoclonal antibodies. • Ensure timely execution of SOP revisions in order to meet project timelines. • Review, trend, analyze, and interpret manufacturing data from ongoing production campaigns to ensure consistent product quality and process performance. • Perform lab-scale experiments to support process changes, generate robustness data, and/or resolve manufacturing non-conformances. • Proactively influence process decisions to help avoid non-conformances. • Provide input on process development strategies. • Routinely present experimental findings (i.e. HPLC) to cross-functional project teams and management. • Seek out, develop and implement emerging technologies and provide input on continuous process improvement.• Track, order and test new products for future use in Cell Culture processes

Listed skills include Biotechnology, Cell Culture, Bioreactor, Good Laboratory Practice, and 6 others.

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  William Paterson University Of New Jersey

  Biotechnology