Job Purpose :
The Project Coordinator Drug Substance and Subject Matter Expert (SME) will be responsible for thesupervision and coordination of all external API activities by reviewing documentation, participating to meetings and workshops, approving related documents, oversee validation campaigns and by contributing to the design of specific development and manufacturing activities. The SME will also be responsible for authoring technical reports that can be used for the regulatory submissions of the drug substance, review and support the authoring of NDA
The Project coordinator and SME is responsible for the management and coordination of all activities related to the project.
- Represent technical DS during internal and external meetings and liaise with key stakeholders.
- Functional representative (DS) in the Vendor Team as a CPR&D member
- Facilitate detailed technical functional sub-team discussions,
- Co-develop and coordinate integrated functional project development and plans for DS and consolidate project related work packages (internal and external) that are delivered through the different departments
- Integrate all aspects of DS, Biologics, and Analytical, to ensure that work packages (internal and external) are initiated, executed and delivered to meet project timelines, milestones and deliverables,
- Identify, communicate, and manage risks associated with the assigned project and to develop appropriate mitigations.
- Proactively plan, track, drive all DS related activities and expenditures in their area of accountability ensuring full adherence quality and timelines ensuring any deviations are appropriately escalated.
- Responsible for risk management for assigned project(s) within the function ensuring all major risks are identified, reported, escalated, and adequately mitigated
- Ensure proactive and timely stakeholder management
- Provide scientific leadership and project management for the assigned project based on phase of development and complexity.
- Contribute to the coordination and review of relevant source documentation from technical function as required for filing/submission and actively support the registration processes.
- Accountable for defining and implementing an integrated DS strategy in collaboration with SMEs functional line management and in alignment with the overall CMC strategy for assigned project(s).
- Oversee Drug Substance development and manufacturing operations. Oversee process optimization, qualification batch manufacturing and process validation and coordinate the technical preparation for the PAI.
- Proactively identify process issues and work collaboratively within the company and the CMO to address challenges.
- Facilitate and support technology transfer activities at CRO/CMO.
- Provide guidance to manufacturing, CMC and QA to ensure compliance with all applicable regulations and assist in resolutions of issues identified.
- Identify and report deviations as appropriate, and typically work to resolve more complex deviations.
- Responsible for authoring technical reports that are the basis of future CMC DS sections of regulatory dossiers and responsible for providing responses to regulatory inquiries.