Nicholas Reitze

About Nicholas Reitze

Bioanalytical and molecular biology assay development/validation and laboratory…

Experience

1. Associate Director of Analytical Sciences and Clinical Testing Services

   Krystal Biotech, Inc.

   Jun 2020 — Present

   Advise, mentor, and provide appropriate department infrastructure to team members in the execution of duties including appropriate orientation and training guides, standard operating procedures, and regularly scheduled one-on-one meeting. • Team includes a mixture of research associates and scientists at many different levels • Manage and coordinate all the in-process and supportive analytical testing for the Process Development and Product Development groups in R&D. Ensure high quality and reliable results are generated and provided quickly to stakeholders. • Manage all the clinical sample analysis in support of all active clinical trials at Krystal Biotech. • Develop analytical methodologies and strategies needed to progress products in the pipeline including method development, process support, formulation and stability support, product characterization and method qualifications within R&D • Monitor scope, milestones, dependencies, and costs associated with analytical projects and the timelines for project deliverables. • Manage short and long-term analytical testing needs for drug substance and drug product and communicate levels to internal project teams. • Strengthen and maintain relationships with the Analytical Development, Quality Control, Clinical Quality Assurance, Product Development, and Process Development teams • Develop and deliver scientific presentations, prepare clear and concise technical reports, participate in project teams. • Validated several key assays necessary to support a phase trial of BVEC (KB103) • Supported IND and BLA regulatory filings Member of Krystal\'s DEI council.