337054BR
May 18, 2022
Slovenia

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.

Analytical Project Lead (m/f/d), the position can be based in Austria, Slovenia, Germany or Switzerland.

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 3 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.
• Proficiency in English.
• Proven leader with experience in managing teams.
• 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.

We offer permanent contract, work in a dynamic environment, collaboration with different teams, knowledge and experience sharing within the global Novartis system. You are kindly encouraged to submit your application, including CV, by 4th of May, 2021.

Why consider Novartis?
769 million. That’s how many lives our products touch. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?

We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.

We are Novartis. Join us and help us reimagine medicine.

Commitment to Diversity & Inclusion:
Novartis embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
Global Drug Development
TECHNICAL R & D GDD
Slovenia
Menges
Germany
Austria
Switzerland
Research & Development
Full Time
Regular
No
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337054BR

Analytical Project Leader - Sen. Expert Sci.&Tec. SI/CH/AT/DE (m/f/d)

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