Cmc Project Manager - Singapore - PRESTIGE BIOPHARMA LIMITED

PRESTIGE BIOPHARMA LIMITED
PRESTIGE BIOPHARMA LIMITED
Verified Company
Singapore

1 week ago

Wei Jie

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Wei Jie

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Description
**Job Responsibilities


Overall Project Management:


  • Oversee project planning, documentation, timelines, and budget management.

Coordination of Quality Section in Dossiers:

  • Coordinate internal and external activities related to the Quality section of dossiers.
  • Provide strategic guidance to technical teams regarding CMC regulatory requirements.

Review and Compliance Oversight:


  • Review technical documents from various teams for accuracy, compliance, and completeness for regulatory submissions.

Due Diligence and Regulatory Agency Meetings:

  • Prepare briefing packages and support cross-functional teams in due diligence and regulatory agency meetings.
  • Engage in negotiations to address and resolve CMC issues.

Dossier Authorship:


  • Ensure final versions align with requirements and meet regulatory agency expectations.

Subject Matter Expertise:


  • Review or approve technical documents (e.g. tech transfer documents) and address or escalate CMC/Quality issues.

Vendor Management and Procurement:


  • Assist in vendor discussions, procurement processes, and shipment activities.

Workflow Optimization:


  • Identify inefficiencies and improve workflows to ensure the efficient operation of the CMC and Bioanalysis department.

Collaboration and Goal Achievement:


  • Collaborate with Team Leaders and members of the CMC Lab and Quality Assurance to ensure department goals are efficiently met.

Regulatory Intelligence:

Stay informed about relevant industry and agency guidance to maintain regulatory intelligence.


Job Requirements

  • A bachelor's, Master, or PhD degree in a relevant scientific discipline (e.g., Chemistry, Biochemistry, Pharmaceutical Sciences).
  • Demonstrated experience in overall project management. Certification in project management (e.g., PMP) would be advantageous.
  • Strong collaborative skills, with the ability to work effectively with crossfunctional teams, vendors, and alliance partners.
  • Meticulous in reviewing technical documents to ensure accuracy, compliance, and completeness.
  • Knowledge of bioprocessing, functional assays and physiochemical characterization of monoclonal antibody is a plus.
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