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:
- 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.
Subject Matter Expertise:
- 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.
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.
- 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.
