Here is the detailed JD:
Role: CMC Product Portfolio Manager
Languages: English
Work mode: Hybrid
Client is looking for a CMC Product Portfolio Manager, more info below
Context:
* The candidate will be responsible for managing a product portfolio and supporting transversal activities from Phase 3 clinical development through to lifecycle management.
Main Responsibilities:
* Take ownership of one or more products in the portfolio.
* Provide a consolidated high-level view of all ongoing activities related to the product, including timelines, milestones, risks, resources, and budgets.
* Ensure regular alignment with Project Managers and other stakeholders across departments (Regulatory, Analytical, QA, DS, DP, Packaging, etc.).
* Represent the portfolio management function in TST (Technical Sub-Team) meetings.
* Participate in the translation of operational activities into planning tools.
* Interact with stakeholders across international locations (US, UK, Switzerland, etc.).
Must-Have Requirements:
* Strong knowledge of the CMC process from Phase 3 through to lifecycle management (understanding of key concepts such as: control strategy, tech transfer, analytical methods, stability, specifications, variation management, etc.).
* Experience in a cross-functional, pharmaceutical/biotech environment.
* Scientific background (Engineer, Pharmacist, Biologist, Chemist, or equivalent – PhD or MSc level).
* Ability to take a step back from operational activities and provide consolidated, high-level oversight.
* Autonomy and strong transversal communication skills.
Nice-to-Have Requirements:
* Experience in project or portfolio management (PM or Portfolio Manager roles).
* Experience with Planisware or other project management tools.
* Knowledge of regulatory and commercial CMC topics.
* Previous exposure to global matrix environments.