Biosimilar Analytics Project Lead

Novartis; Österreich; Hybrid; EUR 59.000 - 72.000; Vollzeit

Benefits dieser Stelle

Pension scheme

Learning and development opportunities

Worldwide career possibilities

Zusammenfassung

Novartis Development seeks an Analytical Project Lead to provide leadership for biosimilar programs as the CDMO. You will represent Analytical Development in the global CMC project team, lead the analytical sub-team across sites and customers, and translate the SoW into executable plans with milestones, resources, and decision points.

You will oversee analytical activities including method development, transfer and validation, and contribute to regulatory submissions while managing timelines,

Qualifikationen

• PhD in life sciences, biotechnology, biochemistry, pharmaceutical sciences or related discipline.
• Strong experience in biologics CMC development, including analytical development and project leadership in late-stage development.
• Ability to lead complex, global, cross-functional development projects in a matrix organization without direct authority.
• Broad scientific and technical understanding of analytical development for biologics.
• Project management capabilities: planning, scope/change, risk, resources and milestones.
• Knowledge of global regulatory expectations for biologics and experience with regulatory submissions.
• Excellent communication, influencing and stakeholder management; building customer relationships.
• Ability to identify issues, develop pragmatic solutions, drive decisions and maintain delivery focus.
• Proficient scientific writing; fluent English (written and spoken).

Aufgaben

• Act as the Analytical Project Lead for assigned biosimilar programs and represent Novartis Analytical Development in the global CMC project team.
• Lead the global cross-functional analytical sub-team in a matrix setup; align objectives, priorities, timelines and decisions.
• Translate the Statement of Work and deliverables into executable analytical plans, milestones, resources and decision points.
• Ensure delivery of analytical work packages by Novartis as the CDMO within agreed scope, quality, timelines and governance.
• Communicate strategy, progress, risks, and recommendations to customer and CDMO roles with clear accountability.
• Provide scientific and technical oversight of analytical activities, including method development, validation and transfer, specs, release testing and stability.
• Lead the preparation and review of high-quality analytical source documents for regulatory submissions, health authority interactions, audits and inspections.
• Identify scientific, technical or GMP issues and drive robust science-based solutions and timely decisions.
• Manage analytical resource and budget needs; support financial planning and delivery within the project framework.
• Communicate project status, priorities, risks, resources and recommendations to senior stakeholders and governance bodies.
• Foster a collaborative, accountable and solution-oriented environment across Novartis Development and external partners.

Jobbeschreibung

Novartis Development seeks an Analytical Project Lead to provide leadership for biosimilar programs as the CDMO. You will represent Analytical Development in the global CMC project team, lead the analytical sub-team across sites and customers, and translate the SoW into executable plans with milestones, resources, and decision points.

You will oversee analytical activities including method development, transfer and validation, and contribute to regulatory submissions while managing timelines,