Senior Manager, Quality Control (CMO)

  • Location

    Singapore

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Salary:

    S$8000 - S$12000 per month

  • Contact:

    Abhik Damani

  • Contact email:

    abhik.damani@voltasia.com.sg

  • Job ref:

    BBBH9107_1617261914

  • Published:

    3 months ago

  • Expiry date:

    2021-05-01

  • Consultant:

    #

My client is a global name in the biotechnology sector and is going through a period of expansion. It now seeks an experienced QC Manager to manage global CMOs based in Europe.

Responsibilities

  • Act as the direct liaison with the QC team within CMOs for all QC related activities
  • Assume responsibility for leading, coordinating and managing all activities associated with QC testing and release during the routine phase.
  • Ensure all QC test methods are being transferred and qualified prior to being used to support clinical and commercial manufacturing
  • Responsible for reviewing QC test reports, test protocols and other associated documents generated from CMOs
  • Perform method monitoring/trending for identified parameters to ensure methods reliability.
  • Work with subject matter experts on the respective methods to provide technical advice to CMOs
  • Ensure necessary equipment qualification and assay validations are complete
  • Prepare responses to audits, deviations, out of specification/lab investigations, customer complaints, and corrective/preventative actions (CAPA)

Requirements

  • Advanced Degree in Biology, Biotechnology, Life Science, or equivalent with at least 8-12 years' experience in a GMP environment
  • Strong understanding of current requirements of Biologics
  • Experience with biochemical analysis - such as immunoassay, cell-based assay
  • Experience in Cell Therapy facilities will be a big plus
  • Prior experience in managing CMOs
  • Excellent communication and negotiation skills
  • Ability to lead a huge team

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).