Jun 07, 2022

Job Description

>200! This the current number of programs in clinical development at Novartis.
Many of these projects, which include new molecular entities, Biosimilars, as well as additional indications and different formulations for marketed products, are for medicines that could significantly advance treatment standards for patients worldwide.

We are a global team of highly skilled analytical project managers with presence in all biologics technical research and development sites of Novartis in Europe, and we are looking for you as an experienced, curious, inspiring Analytical Project Leader to join our team to support development of biologic products.

Your key responsibilities
• You will lead and coordinate the analytical sub-team and represent the analytic discipline in the global CMC project team of assigned projects.
• You are accountable for managing all analytic related activities of drug product and drug substance development including release and stability-testing, characterization of the API, method-development, -transfer and -validation, specification setting, know-how transfer etc.
• You will need to communicate effectively across organizational interfaces i.e. project-management, line functions, senior management, etc.
• You will proactively identify scientific, technological and GMP issues, propose creative solutions and communicate key issues to the appropriate management level
• You are responsible for high quality analytical registration documents for HA submissions and interact with authorities, act as technical expert in audits, inspections etc.
• You are responsible for analytical budget and resource planning

Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum Requirements

What you will bring to the role
• PhD and minimum of 8 years relevant experience of Biologics CMC development or University life-science degree with appropriate industry experience
• Previous experience in analytical areas in biologic drug development in an industrial setting
• Excellent understanding of regulatory expectations and requirements with significant experience with IND/ BLA submission
• Proficiency in English
• Proven leader with minimum of 5 years experience in managing teams/ projects
• Proven track record of creativity, problem solving and productivity
• Proficient scientific/technical writing skills

Desirable Requirements:
• Demonstrated excellent communication, presentation and management skills
• Worked in interdisciplinary teams with excellent theoretical and scientific knowledge of product development

We are looking for responsible, objective-driven candidates who value collaboration, team work and are open to new challenges and expanding their knowledge and expertise.
Global Drug Development
Research & Development
Full Time
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Analytical Project Lead - Associate Director

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