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 € 78,383.90 a 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. Our hiring decisions are 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 the recruitment process due to an illness, physical disability or neurodiverse condition, please contact [email protected] and 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 local disability 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 our career 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?  http://www.novartis.com/about/strategy/people-and-culture