Bogdan Milosevic

Experience

1. Director of Quality Control

   Editas Medicine

   Sep 2021 — Present · Cambridge, MA, US

   Manage QC systems and all related activities.Direct the QC teams in the implementation of all methods for in-process, release and stability testing for Editas\' products and reference materials.Direct timely interpretation of testing results and trending of data to ensure conformity with quality specifications, including review of assay performance; and works with analytical development and R&D as needed to ensure methods and results are as expected. Manage initiatives to improve QC processes, cost effectiveness, enhancing efficiencies, safety and compliance of processes and procedures within current regulatory standards. Ensure testing is in accordance with SOP\'s and regulatory requirements Oversight of external Quality Control testing. Establish internal QC testing capabilities as needed and ensure it is supported with appropriate infrastructure and equipment, validation, personnel, training to ensure cGMP compliance. Facilitate Review and approval of manufacturing documentation in support of externaland internal GMP activities (batch records, analytical data, etc.).Interface with business partners and external vendors to ensure Quality Control activities are prioritized and completed on time and with a high degree of quality.Participate in external and external audits in compliance with internal procedures including CMO’s, CTO’s and supplier audits.Support regulatory document review and submissions

Skills

• Validation
• Gxp
• Aseptic Processing
• Capa
• Quality System
• Molecular Biology
• Technology Transfer
• Hplc
• Lims
• Immunoassays
• Change Control
• Cell
• Microbiology
• Biotechnology
• Biopharmaceuticals
• Pharmaceutical Industry
• Sop
• Fda
• 21 Cfr Part 11
• Glp
• Assay Development
• Quality Control
• Gmp