Patrick Kritz Email & Phone Number

Downingtown, PA, US

King Of Prussia, Pennsylvania, United States

Process design, facility start up and operations support of plasmid and nucleic acid manufacturing

King Of Prussia, Pennsylvania, United States

Lead cross functional team through the process technology transfer of key purification unit operations, delivering engineering and process validation manufacturing campaigns in support of new product introduction and increased product manufacturing capacities Deliver process standardization and continuous improvement initiatives targeting reduction in.

King Of Prussia, Pennsylvania, United States

Designed, generated and executed study protocols and reports facilitating process qualification and optimization activities within a cGMP environmentDeveloped process control strategies, utilizing tools such as parameter-attribute matrices to identify critical process parametersExecuted major process deviation investigations, implemented associated.

King Of Prussia, Pennsylvania, United States

Authored sections of regulatory CMC product file and provided responses to follow up questions from regulatory agencies Participated in regulatory agency inspections (product pre-approval and periodic inspections), ensuring product safety and compliancePerformed at-scale process equipment qualification, including mixing vessel and mass transfer.

King Of Prussia, Pennsylvania, United States

Supported at-scale process equipment qualification and process technology transfer activities in support of the introduction of a monoclonal antibody manufacturing process at a 5000L scaleConducted process and equipment risk assessments including material extractables and leachables, filter material compatibility, and new equipment implementation

Spring House, PA

Member of a cross-functional device team responsible for the redesign of a combination product (drug reconstitution and delivery system) produced for the treatment of schizophrenia and Bipolar I Disorder. Learned the essentials of FDA validation practices and general operation within a design control environment.Developed fixtures, test methods, and.

Doylestown, PA

Supported the design and manufacture of optical filters, coatings and components to enhance the optical and environmental performance of electronic displays and precision optics. Responsibilities included material property testing, manufacturing fixture design and implementation, processing returns, and drafting work instructions.