Analytical Project Lead, Biosimilar CDMO (m/f/d)

Your Profile:

• PhD in life sciences, biotechnology, biochemistry, pharmaceutical sciences or a related discipline, with relevant pharmaceutical industry experience, or an equivalent scientific degree with substantial relevant experience.
  
• Strong experience in biologics CMC development, including experience in analytical development and project leadership particularly in late staged development.
  
• Demonstrated ability to lead complex, global and cross-functional development projects in a matrix organization without direct authority.
  
• Broad scientific and technical understanding of analytical development for biologics.
  
• Project management capabilities, including integrated planning, scope and change management, risk management, resource and budget planning, stakeholder alignment and milestone delivery.
  
• Good understanding of global regulatory expectations for biologics development and experience contributing to regulatory submissions and health authority interactions.
  
• Good communication, influencing and stakeholder management skills, with the ability to build effective customer relationships and navigate organizational interfaces.
  
• Ability to identify critical issues, develop pragmatic solutions, drive decisions and maintain delivery focus in a dynamic environment.
  
• Proficient scientific and technical writing skills and fluent English, written and spoken.

Your Tasks:

• 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 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 setting, release testing and stability programs.
  
• Lead the preparation and review of high-quality analytical source documents and contributions supporting regulatory submissions, health authority interactions, scientific advice, audits and inspections.
  
• Be accountable for identifying scientific, technical or GMP issues, and drive robust, science-based solutions and timely decisions.
  
• Be accountable for analytical resource and budget needs, support financial planning and tracking, and manage delivery within the agreed project framework.
  
• Communicate project status, priorities, risks, resource needs and recommendations effectively to senior stakeholders and relevant governance bodies.
  
• Foster a collaborative, accountable and solution-oriented working environment across Novartis Development and external partners.

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