CMC Operational Planning & Capacity Manager

Main Responsibilities:
- Own the accuracy of each assigned therapeutic project plan in the Planisware planning tool, ensuring CMC strategy is reflected in project logic, timelines (incl. CMC High Level Plan), and resource workload.
- Provide workload and capacity analysis and reporting to support the CMC Project Team and CMC Managers (if Function Business Partner), including scenario development to optimize timelines/resources and support site re-allocation or outsourcing decisions for bottlenecks.
- Analyze deliverable timelines and critical path activities to support CMC risk management assessments.
- Ensure alignment of CMC activities with global strategic project planning and cross-functional operational planning (Translational Medicine, Clinical Sciences, Regulatory Affairs) with proper integration in the planning tool.
- Attend relevant CMC Project Team/planning meetings related to timelines, resources, governance preparation, and CMC Function reviews.

Basic Qualifications:
- Education: Bachelor’s, Master’s, PhD, or MBA in a scientific/technical/business field (e.g., Pharmacy, Engineering, Biology, Chemistry, Business Administration) or equivalent.
- Experience: 5+ years (Bachelor’s), 3+ years (Master’s/MBA) or 2+ years (PhD) in project planning/management and/or CMC operational/laboratory activities in a regulated pharma/biotech environment.

Preferred Qualifications:
- Proactive adoption of Digital and/or AI solutions.
- Biologics and/or Gene Medicine CMC operations experience.
- Familiarity with AAV or LNP platforms.
- Planning/project management tools knowledge (e.g., Planisware).
- PMP or CAPM.
- Tableau/Power BI or advanced Excel.
- Knowledge of finance and budget management.