Chris Sebranek

About Chris Sebranek

Senior Manager with significant GMP experience (Biotechnology, Pharmaceutical and Medical Device) including: design, construction, validation and clean room management. Experience in implementing Quality Systems. Extensive knowledge of single use systems. Developed GMP manufacturing infrastructure for: Upstream, Downstream, Cell Banking, Materials Management, Facilities, EHS and Metrology. Expertise in technical transfer process to ensure efficient flow of information from process development to GMP manufacturing. Supported continuous improvement opportunities including training for Lean and Six Sigma concepts.

Experience

1. Sr Director Quality and Regulatory

   SHINE Technologies

   Sep 2023 — Present · Janesville, WI, US

   Sr Director Quality and Regulatory position will focus on SHINE Technologies’ production of GMP compliant radio chemicals with the facilities in Wisconsin with plans to expand into Europe. This role will lead our quality initiatives and work across all departments to ensure compliance to SHINE’s Quality Systems in a Global Market. This person will lead our regulatory submission processes in accordance with our internal procedures and the regulatory requirements for our various target markets. This role is accountable for ensuring company processes are adhered to and relevant quality and regulatory guidelines and timelines are considered and implemented as applicable.

Education

• University of Wisconsin-Green Bay

  BS, Biology

  1974 — 1978

• University of Wisconsin-Madison

  MS, Biotechnology

  2005 — 2007

Skills

• Quality System
• Single Use Technology Systems (Disposable Systems)
• Clean Room Design
• Standard Operating Procedure (Sop)
• Quality Assurance
• Project Management
• R&D
• Gmp
• Risk Assessment
• Root Cause Analysis
• Technology Transfer
• Validation
• Pharmaceutical Industry
• Sop
• Fda
• Operational Excellence
• Medical Devices
• Vaccines
• Biopharmaceuticals
• Biotechnology
• Ehs
• Clean Room Management
• Research and Development (R&D)
• U.s. Food and Drug Administration (Fda)
• Manufacturing