Rostyslaw “Rusty” Kutny M.Sc.

RK Quality Consulting LLC

Quality and Analytical Expert

Rusty is a quality and technical professional with 35+ years pharmaceutical experience in biopharmaceutical Quality Assurance, R&D, Quality Control, with escalating managerial responsibilities.

He possesses excellent team development skills in intra-department and cross-functional area with effective oral and written communications skills, as well as strong analytical technical knowledge for root cause analysis to problem solving of facility, production and analytical related issues.

His goal is to utilize his technical knowledge and GMP experience in Quality Systems to provide for QC- and QA-related tasks and/or issues, especially at API manufacturing sites or aseptic Fill&Finish facilities.

He is qualified to establish and build QA & QC functions including developing SOPs for GMP manufacturing and is well versed in cGMP and regulatory guidelines to meet FDA, EU and MFDS requirements.

Experience (selection)

  • 2010 to date: President and CEO of RK Quality Consulting LLC, USA
  • 2009 to 2010: Director Quality Control at Auxilium Pharmaceuticals, USA
  • 2004 to 2009: Vice President Quality Control and Quality Assurance at Celltrion, South Korea
  • 1996 to 2004: Senior Biochemistry Specialist (2 years), Assistant Director QA (2 years), Manager Quality Control (4.5 years) at (Glaxo)SmithKline Beecham, USA
  • etc.

Education

  • M.B.A. in Computer Science at University of Delaware, USA
  • M.B.A. in Pharmaceutical Marketing at Farleigh Dickinson University, USA
  • M.Sc./M.B.A. in Biochemistry at Rutgers University, USA

Milestones and Achievements

  • 2010: Founding of RK Quality Consulting, LLC
  • Established and directed Quality Systems in support of biopharmaceutical production from pilot plant scale 500L to 12,5000L multi-product manufacturing site (including QC laboratory design, QA compliance, Quality Systems and technical support of facility validation)
  • Managed CMO QC to QC transfers and validation, including strategic plan for design, implementation and maintenance of the Quality Systems for inspection readiness.
  • Established several QC / Quality departments (12-50+ team members) from pilot scale to Large Scale Manufacturing sites which included hiring staff, training and developing teams to support Facility utilities and EM testing, cleaning validation and changeover programs, product stability program and BDS release testing and all SOPs to support such Quality Operations and manufacturing activities
  • Conducted independent quality audits of laboratory compliance activities under GLP and cGMP, and evaluated R&D laboratory quality practices.