John Kautz Email & Phone Number

Gaithersburg, Maryland, United States

Gaithersburg, Md

Drug Product technical lead in commercial interface teams at external manufacturing sites and CMOs.Leading technical evaluation and implementation of complex drug product change controls for commercial productsCommercial process monitoring by leading regular trending and review of CPV dataCommunicating pertinent information to appropriate leadership and CMC teamsDeveloping long term commercial drug product manufacturing improvements to increase yield and provide technical input… Show more Drug Product technical lead in commercial interface teams at external manufacturing sites and CMOs.Leading technical evaluation and implementation of complex drug product change controls for commercial productsCommercial process monitoring by leading regular trending and review of CPV dataCommunicating pertinent information to appropriate leadership and CMC teamsDeveloping long term commercial drug product manufacturing improvements to increase yield and provide technical input to external manufacturing organization.Consultation on technical transfer projects and validation activities for existing and pipeline products. Show less

Gaithersburg, Md

Technical leadership in drug product and combination product processes for AstraZeneca. Technical transfer, process performance qualification and commercial support for drug products.

Technical oversight for the development of commercial scale drug product manufacture, including process validation,aseptic qualification, and analytical validation.Development and review of technical transfer packages, serving as a Person-in-the-Plant for manufacturing and testing, Identification and qualification of subcontractors for manufacturing and testing, developing and coordination of process validation master plans, drafting validation protocols, performing reviews of… Show more Technical oversight for the development of commercial scale drug product manufacture, including process validation,aseptic qualification, and analytical validation.Development and review of technical transfer packages, serving as a Person-in-the-Plant for manufacturing and testing, Identification and qualification of subcontractors for manufacturing and testing, developing and coordination of process validation master plans, drafting validation protocols, performing reviews of validation plans and protocols, performing reviews of technical specifications, protocols, technical reports, Drafting and technical review of Master Batch Production and complete batch production and testing records that are related to the manufacture and/or testing of DVC’s products. Applying technical knowledge of biologics manufacturing along with current Good Manufacturing Practices (CGMP) and Good Laboratory Practices (GLP) on a daily basis. Show less

Provided engineering and validation support for biologics and pharmaceutical pilot plant operations.Cultivated significant experience in GMP documentation review, including protocols and change control requests.Supported cleaning validation for new and existing equipment necessary for the production of clinical material, including bioreactors, chromatography skids, homogenizers and glass washers.Supervised off-shift Quality Engineering hourly staff.

Provided technical support to Sterile Manufacturing for pharmaceutical and biological products.Investigated atypical events, prepared and provided master formulas to production, and headed process improvement initiatives. Initiated and implemented process changes and improvements, including coordinating validations, master formula revisions, standard operating procedure updates, training and floor support. Trained new personnel to the department on policies and process… Show more Provided technical support to Sterile Manufacturing for pharmaceutical and biological products.Investigated atypical events, prepared and provided master formulas to production, and headed process improvement initiatives. Initiated and implemented process changes and improvements, including coordinating validations, master formula revisions, standard operating procedure updates, training and floor support. Trained new personnel to the department on policies and process operations.Supported the startup of barrier technology biologics formulation facility, including GMP documentation, process optimization and facilitation of operations and validation personnel. Investigated atypical events in manufacturing and lead changes for continuing corrective actions. Implemented plans for sterile filtration, lyophilized product stopper drying and other process improvements. Show less

Ms, Chemical Engineering

Activities and Societies: Homebrewing club, Chemical Engineering Student Council, intramural sports team captain. Masters degree.

Bche, Chemical Engineering

Activities and Societies: Tau Beta Pi, AIChE, ACS, Honors Program Bachelors degree in Chemical Engineering, including undergraduate.