W1siziisimnvbxbpbgvkx3rozw1lx2fzc2v0cy92b2x0lwfzawevanbnl2pvynmtymfubmvylwrlzmf1bhquanbnil1d

Senior Specialist, MSAT

Senior Specialist, MSAT

  • Location

    Singapore, Singapore

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Salary:

    S$6000 - S$9000 per month

  • Contact:

    Abhik Damani

  • Contact email:

    abhik.damani@voltasia.com.sg

  • Job ref:

    BBBH6780_1559893281

  • Published:

    3 months ago

  • Expiry date:

    2019-07-07

  • Consultant:

    #

My client is a leader in the biotechnology space and now are going through a phase of rapid expansion. To cater to this, they now seek an experienced MSAT Process Specialist to join them

This role will be reporting to the Head of MSAT

Responsibilities:

  • Assume primary responsibility for technical support to manufacturing operations to ensure that processes meet cGMP requirements
  • Lead data collection, process monitoring, deviation closure, process troubleshooting, and optimization activities related to manufacturing
  • Demonstrate knowledge and understanding of pharmaceutical processing and associated cell culture and harvest unit operations including equipment operation, design and control
  • Provide floor support, troubleshoot unit operations, and resolve and document investigations to support cGMP production
  • Ensure timely closure of deviations, change control and qualification activities.
  • Support quality, process development and manufacturing operations in ensuring the process control strategy is maintained and monitored
  • Lead and assist in process troubleshooting and process monitoring trending systems and tools that align with the QMS and are part of the process verification plan
  • Maintain strong working relationships with inter-department stakeholders as well as external contractors
  • Mentor junior process engineers and specialists

Requirements:

  • Advanced Degree in Engineering, Biotechnology or equivalent with at least 7 - 10 years of relevant working experience
  • Experience with cell therapy and upstream/downstream process will be a big plus
  • Prior experience in process troubleshooting, deviation writing and executing change controls, particularly in a clinical or commercial manufacturing setting.
  • Comprehensive experience in cGMP quality systems including process monitoring, non-conformances, change controls and CAPA
  • Familiar with Six Sigma Methodologies
  • Travel of about 20%

Please send your resume in WORD format by clicking the apply button below or contact Abhik Damani on +65 6701 1527 for a confidential discussion. Please note that only short-listed candidates will be contacted. CEI Reg. Number R1544061 (Abhik Damani).