- Oversee project planning, documentation, timelines, and budget management.
- Coordinate internal and external activities related to the Quality section of dossiers.
- Provide strategic guidance to technical teams regarding CMC regulatory requirements.
- Review technical documents from various teams for accuracy, compliance, and completeness for regulatory submissions.
- Prepare briefing packages and support cross-functional teams in due diligence and regulatory agency meetings.
- Engage in negotiations to address and resolve CMC issues.
- Author and drive completion of the Quality section of dossiers for clinical trial and marketing authorization applications.
- Ensure final versions align with requirements and meet regulatory agency expectations.
- Monitor activities of CMO/CDMO and provide CMC subject matter expertise.
- Review or approve technical documents (e.g. tech transfer documents) and address or escalate CMC/Quality issues.
- Assist in vendor discussions, procurement processes, and shipment activities.
- Identify inefficiencies and improve workflows to ensure the efficient operation of the CMC and Bioanalysis department.
- Collaborate with Team Leaders and members of the CMC Lab and Quality Assurance to ensure department goals are efficiently met.
- Stay informed about relevant industry and agency guidance to maintain regulatory intelligence.
- 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.
- In-depth knowledge and understanding of Chemistry, Manufacturing, and Controls (CMC) regulatory requirements and processes, particularly in the authoring or management of Quality sections of dossiers for clinical trial and marketing authorization applications of biologics drug.
- Strong collaborative skills, with the ability to work effectively with cross-functional 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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CMC Project Manager - Singapore - PRESTIGE BIOPHARMA LIMITED
Description
Roles & ResponsibilitiesJob Responsibilities
Overall Project Management:
Coordination of Quality Section in Dossiers:
Review and Compliance Oversight:
Due Diligence and Regulatory Agency Meetings:
Dossier Authorship:
Subject Matter Expertise:
Vendor Management and Procurement:
Workflow Optimization:
Collaboration and Goal Achievement:
Regulatory Intelligence:
Job Requirements
Biochemistry
Construction
Due Diligence
Budget Management
Quality Assurance
Project Planning
Chemistry
Procurement
Vendor Management
Compliance
Project Management
Authorization
Characterization
Regulatory Requirements
Regulatory Submissions
Manufacturing