Summary
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 an experienced, curious, inspiring Analytical Project Leader to join our team in Austria to support development of our biologic product pipeline.
The Analytical Project Leader (APL) is the strategic lead of analytical development (AD) and is accountable for agreed upon deliverables to the CMC team and scientific content for the development program.
About the Role
Your tasks include:

• Represent Analytical Development on the CMC core team & lead the global analytical sub-team with cross functional members
• Lead and coordinate timely delivery of high quality source documents for submission, review of regulatory documents (e.g. CMC modules, briefing books) and interact with Health Authorities in audits and scientific advice meetings
• Proactively communicate overall project strategy, assess and consolidate resource needs (internal and external costs) and set priorities for the analytical sub-team.
• Support the growth of the sub-team members and motivate them as appropriate through encouragement and servant leadership.
• Lead and manage all analytics 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.
• Critically evaluate results and draw relevant conclusions.

What you bring to the position:

• PhD and minimum of 8 years' relevant experience in 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.
• Fluency 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, teamwork and are open to new challenges and expanding their knowledge and expertise.
What we offer:
In addition to a basic salary in line with the market, we offer an attractive bonus/incentive program, a modern company pension, childcare facilities, 14 weeks of fully paid parental leave, training and development programs and worldwide career opportunities within the Novartis Group. In accordance with Austrian law, we are obliged to disclose the minimum salary as stated in the collective bargaining agreement. For this position the minimum salary is € 78,383.90a year (on a full-time basis).
Commitment to diversity and inclusion:
Novartis is committed to diversity, equity, and inclusion. We strive to build diverse teams that are representative of the patients and communities we serve. We strive to create an inclusive workplace that fosters bold innovation through collaboration and empowers our employees to reach their full potential. Ourhiring decisionsare based on equal opportunity and the best qualifications, regardless of gender, religion, age, colour, race, sexual orientation, nationality or disability.
Support for applicants with disabilities:
If you need support in different parts of therecruitment processdue to an illness, physical disability or neurodiverse condition, please contactdisabilities.austria@novartis.comand let us know the nature of your request as well as your contact information. Our support includes advice on suitable positions as well as support in all phases of the application process. Austrian law provides for the possibility of involving the localdisability representative(BVP) in the application process. If you wish to do so, please let us know in advance as a note in your CV.
Join our Novartis Network:
If this position does not fit your experience or career goals, but you still want to stay in touch with us to learn more about Novartis and ourcareer opportunities, then join the Novartis Network here:talentnetwork.novartis.com/en_US/network
Why Novartis:Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
Benefits and Rewards: Read our handbook to learn about all the ways we'll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards