As CMC Project Management Professionals, we proactively manage multiple CMC projects coordinating with key internal and external stakeholders. We work collaboratively with a focus on effective communication, planning, coordination of activities, and efficient implementation of the CMC development and supply strategy. This will include working with your CMC, clinical, and regulatory groups, external academic partners, and Contract Manufacturing Organizations (CMOs) and Contract Research Organizations (CROs).
Here’s What We Will Do For You:
- Establish, manage and lead cross-functional CMC project teams for assigned programs
Represent CMC Project Management on Early and Late Stage Technical Development Team(s)
Create and maintain detailed CMC project plans to ensure clarity of deliverables and timing for IND/NDA/ANDA Projects
- Track project tasks and efforts associated with process development, analytical development, pharmaceutical development, manufacturing, quality, and supply chain
- Identify new raw material and consumable requirements for early stage projects
- Coordinate CMC development team, including scheduling and facilitating meetings, sending out agendas, writing and distributing minutes, managing team documentation, and tracking goals and action items
- Support the development of Statements of Work (SOW) contracts for partnered programs, work with technical subject matter experts, legal, finance as required to define scope and budget, facilitate the negotiation and execution of SOWs; track deliverables
- Work with Finance for invoicing/revenue forecasting for partnered programs
- Be responsible for the strategy development and creation of CMC submission documents from early phase clinical submissions through to marketing applications and post approval activities.
- Understand, interpret and advise teams on regulations, guidelines, procedures and policies relating to development, registration and manufacture of new bio/pharmaceutical products, to expedite submission, review and approval of global CMC applications.
- Work with cross-functional matrix project teams, which include colleagues from regulatory, biopharmaceutical development and manufacturing.
- Working with the Global Development team to integrate CMC strategy considering the interdependencies with clinical, regulatory, and commercial timelines.