CMC Product Portfolio Manager

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.