Analytical Project Lead, Biosimilar CDMO (Requena)

Analytical Project Lead, Biosimilar CDMO (Requena)

07 set
|
Biopharma Careers
|
Requena

07 set

Biopharma Careers

Requena

We are a global team of analytical project leaders within Novartis Development, supporting the development of biologic medicines across a complex, cross-functional environment. We are seeking an Analytical Project Lead to provide analytical leadership for biosimilar programs that Novartis develops as a CDMO. In this role, you will be accountable for delivering the analytical development strategy and its execution within the agreed Statement of Work. You will represent the Novartis Analytical Development in the global CMC project team, lead the analytical sub-team across Novartis functions and sites and customers. The position combines strong project management, scientific leadership, and effective customer-facing collaboration. It is an expert role with matrix leadership responsibility. #LI-HybridLocation - Schaftenau, Austria Temporary position, 2 years. Finishing end of September 2028

Your key responsibilities
- Act as the Analytical Project Lead for assigned biosimilar programs and represent Novartis Analytical Development in the general CMC project team.
- Lead the global,



cross-functional analytical sub-team in a matrix setup and align on objectives, priorities, timelines, interfaces and decisions.
- Translate the Statement of Work and agreed customer deliverables into executable analytical plans, milestones, resource requirements and decision points.
- Ensure delivery of analytical work packages by Novartis as the CDMO, in accordance with agreed scope, quality standards, timelines and governance.
- Proactively manage dependencies, risks, changes and escalation needs.
- Ensure transparent communication of strategy, progress, risks, scientific recommendations and decisions while maintaining clear accountability between customer and CDMO roles.
- Provide scientific and technical oversight of analytical activities performed within Novartis and, where required, at contract laboratories, including analytical method development, validation and transfer, specification

📌 Analytical Project Lead, Biosimilar CDMO (Requena)
🏢 Biopharma Careers
📍 Requena

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