Senior Manager, Process Development

  • Location

    Singapore

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Salary:

    S$11000 - S$14000 per month + transport allowance

  • Contact:

    Abhik Damani

  • Contact email:

    abhik.damani@voltasia.com.sg

  • Job ref:

    BBBH7786_1579830339

  • Published:

    9 months ago

  • Expiry date:

    2020-02-23

  • Consultant:

    #

My client is a world leader in the healthcare industry and are going through a period of rapid expansion. To cater to this, a new role of a Senior Manager, Process Development has been made available.

Reporting to the Global Headquarters to the VP, Process Development, the Senior Manager will lead a group of 5-6 analytical scientists

Responsibilities:

  • Drive product quality attribute and process development support of commercial Biological and Synthetic products
  • Liaise closely and collaborate with leaders from key functions within Process Development, Manufacturing and Quality
  • Act as a Process specialist with a holistic chemical / biotech engineering background and experience in the production of drug substance (Cell culture and harvest operations)
  • Coordinate multiple, complex, non-routine activities including facility start up, process qualification through to regulatory approval, process performance monitoring, floor support, troubleshooting of unit operations and technology transfer of new processes
  • Sustain attribute focused analytical methods, support small scale model and forensics studies, and participate in method transfer activities.
  • Provide scientific support for analytical methods in quality control labs, and manufacturing

Requirements:

  • PhD/Masters in Biological Sciences, Biochemistry, Analytical Sciences or equivalent with at least 10 years of experience in applying analytical methods in biologics/small molecule development
  • Solid understanding of product quality attributes control strategies
  • Strong working knowledge of regulatory expectations related to analytical control strategies
  • Experience in developing quantitative mass spectrometry methods for characterization, quality control testing and disposition of biologics
  • Prior working experience in matrix environment to support CMC development
  • Knowledge of Validation Lifecycle Approach and experience in regulatory submissions
  • Excellent team management and leadership capabilities

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).