Analytical Project Leader (APL) (m/f) 80-100%

324459BR
Aug 30, 2021
Switzerland

Job Description

200! This the current number of programs in clinical development at Novartis. Many of these projects, which include new molecular entities 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 looking to hire an experienced Analytical Project Leader (APL) to strengthen our team in Basel and help us advance Novartis’ Cell and Gene Therapies pipeline.
Your area of responsibility:
• You will lead and coordinate the analytical sub-team and represent Analytics in global CMC project teams of assigned cell & gene therapy development projects
• You are accountable for managing all analytical activities for assigned projects, including the development of analytical methods for release and characterization testing, method handover and transfer, specification setting, etc.
• You are able to communicate effectively across organizational interfaces, e.g. with different line functions, project management, regulatory affairs, etc.
• You 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 regulatory submissions
• You will interact with authorities and act as technical expert in audits or inspections
• You will contribute actively to budget and resource planning


Minimum Requirements

Minimum requirements / education
• PhD with several years directly related experience
Experience / key competencies
• Proven experience leading analytical efforts for biopharmaceutical and / or cell & gene therapy products is a must
• Prior experience in the development of lentiviral vectors is a plus
• Excellent understanding of regulatory expectations and requirements for cell & gene therapy products / ATMPs
• Good communication, presentation, and management skills
• Language proficiency: English mandatory, German desirable

3000! highly committed associates in Technology Research & Development, with a presence in 8 countries, 17 locations. We enable innovative therapies to improve and extend patient’s lives by leading technical development in collaboration with internal and external partners. We make Novartis medicine work.

Engagement für Vielfalt und Inklusion:

Novartis setzt sich für Vielfalt, Chancengleichheit und Integration ein. Wir engagieren uns für den Aufbau vielfältiger Teams, die repräsentativ für die Patienten und Gemeinschaften sind, denen wir dienen, und wir streben danach, ein integratives Arbeitsumfeld zu schaffen, das mutige Innovationen durch Zusammenarbeit fördert und unsere Mitarbeitenden befähigt, ihr volles Potenzial zu entfalten.

*Einige Einschränkungen für flexible Arbeitsmöglichkeiten können gelten und werden gegebenenfalls im Vorstellungsgespräch besprochen.

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Global Drug Development
TECHNICAL R & D GDD
Switzerland
Basel
Research & Development
Full Time
Regular
No
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324459BR

Analytical Project Leader (APL) (m/f) 80-100%

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