Michael Dux Email & Phone Number

New York, New York, Us

New York, New York, Us

• Site head for MS&T group with 25 Scientists and Engineers • Technical Expertise for process-related deviations (PRs). Technical root cause analysis• Support product supply, launch teams, and manufacturing for a North American business with >600M units produced annually.• Successful transfer of two 3rd party products within 4 months• Delivered > $6M in annual cost savings• Development of scale-up/ scale-down models-Enables product re-starts with minimal line time- Faster troubleshooting• Investigational analytics to support manufacturing deviations

• Lead and be accountable for international and local projects such as the development ofproducts, the technical development part of projects or technical operational projects• Develop and implement project strategies and scope to achieve objectives in optimal timelineand budget and achieve critical project milestones. • Lead Technical Project Teams of experts responsible for Chemical, Analytical,Formulation and Packaging Development, Technical Development US and International ProductionManagement OR International Project Teams of experts representing TechnicalProject Management, DMPK & Safety, Efficacy, Marketing, and Regulatory Affairs.• . Align project objectives and priorities with team members. Organizeand chair team meetings.• Support/lead teams with strong strategic focus, quality awareness, scientific and technical expertise.• Facilitate and implement scientific, project and organizational innovation for new or existingveterinary product ideas and the improvement of R&D and Technical Operational processes.• Portfolio and project management of Vaccine and Pharmaceutical projects

• Lead the Process and Analytical Development groups in the R&D department• Manage the capital and project budgets• Successful technology transfers, process validations and on-time delivery of R&D projects to GMP manufacturing facilitys.• Registration of several EU, SAG, CFIA, and USDA products.• Lead and participated in collaborations with other BU’s and 3rd parties.• Writing and implementation of QM’s, GOP’s, SOP’s, IQ,OQ, PQ CSV, technical reports and technology transfer documents• Active career development of my team and other members of the R&D team.

•Developed vaccine process and transferred to the manufacturing facilities.•Lead, developed and transferred process improvement projects to the manufacturing facility. Reducing COG’s, improving yields, and improving efficiencies. •Leader of many different cross functional teams. •Final Formulation development for final product stability •Process development at production and Bench scale Ultra-Filtration / Dia-Filtration using Flat Sheet, Cassettes, and Hollow Fiber Membranes

•Assisted in the design and construction of pilot and laboratory facilities.•Developed small scale purification and fermentation processes, scaled-up, and transferred the processes to other cGMP CMO facilities •Operator in a Pilot Plant for the manufacturing of cGMP pharmaceuticals.•Responsible for operation and development of numerous Bacterial and Yeast production processes •Process design of new media, and growth conditions for bacterial Fermentations •Production and Bench scale Ultra-Filtration / Dia-Filtration using Flat Sheet, Cassettes, and Hollow Fiber Membranes •Utilizing Windows-based PCs with various software: MathCad; Microsoft Office: Excel, Word, Power Point, Lotus, Aspen Design Studio, Bio-Command, Applied Bio-systems software, and many different PLC controllers

Master Of Science (Ms), Chemical And Biomolecular Engineering

Bs, Chemical Engineering

Mba, Project Management