Ananya Das

About Ananya Das

Manufacturing Specialist (Process Owner) with extensive experience in Process Design…

Experience

1. Manufacturing Specialist

   Amgen

   Feb 2022 — Present

   Participate in technology transfer, and new product introduction (NPI) process to assess requirements for documentation, materials, training, and equipment modification. Assess, prioritize, justify, and provide implementation and project management support for process or equipment modification projects • Provide assessment on Change control (CCRB) records impacting the process as a manufacturing change owner • Review and approve user requirement specifications (URS), and functional specifications (FS) and provide support in Factory acceptance test (FAT), and Site acceptance test (SAT) as a manufacturing process owner • Lead design and process review sessions with cross-functional team to align the process parameters to assist in process validation and generation of process validation protocols and reports while supporting collection and analysis of process validation data • Draft, review and own the standard operating procedures (SOPs), work instructions (WI), and training materials for new production lines (L001 and L002) • Develop and update process flow diagrams (PFD) including material and personnel flow as a training material for teams • Support in overall operational readiness of the commercial production of the packaging lines (L001 & L002) in the new facility

Education

• Govt. M. M. City college

  Higher Secondary School Certificate, Science

  2008 — 2010

• The University of Toledo

  Master's degree, Chemical Engineering

  2018 — 2021

• Bangladesh University of Engineering and Technology

  Chemical Engineering

  2010 — 2016