Summary
At Technical Research & Development - Biologics, we are dedicated to bringing innovative scientific solutions to our patients. Our commitment to excellence drives us to develop cutting-edge biologic drug products that enhance the quality of life of patients.
We are looking for a passionate Scientist to join our team and lead a wide range of activities from formulation and process development to technical transfer and submission support.
As a Senior Expert you will play a key role in the development of Biologics Drug Products and be part of an international, collaborative team, located in Schaftenau, Austria. It is an exciting time to join us on our journey to reimagine medicine for patients!
About the Role
Your responsibilities:
As Functional Lead you will lead, own and drive the scientific strategy and all deliverables within complex Biologic Drug Product development projects and you will be a core member of the Drug Product development sub-team, representing scientific and technical excellence.

• Independently design, plan, perform or supervise technical and scientific activities for product and process development in close alignment with the respective project manager and lab scientists.
• Deliver development work packages to meet agreed objectives & timelines in the project team and ensure information exchange in the Drug Product sub-team.
• Interpretation of results from scientific / technical activities, drawing relevant conclusions and presentation of data to relevant sub-teams.
• Lead, manage and execute the technology transfers of drug product manufacturing processes from development sites to internal/external manufacturing sites.
• Writing and reviewing of high-quality reports for submissions preparation, review of regulatory CMC documents and contribution to interactions with health authorities and audits as subject matter expert.
• Drive and support Root Cause Investigations (RCIs) as well as trouble shooting activities including development of solutions, mitigation plans and reporting risks.
• Work according to appropriate laboratory standards for quality, ethics, health, safety, environment protection and information security.

In your role as Functional Lead, you will further support the Drug Product Science Team with the following responsibilities:

• Lead and contribute to key scientific initiatives and workstreams to develop short & long term drug product development strategies for the Biologics pipeline.
• Present scientific or technical results to different audiences within Novartis or externally.
• Ensure knowledge sharing and support the growth of junior team members.

Requirements:

• Ideally PhD or Master in pharmaceutical technology, biotechnology, chemical engineering or other relevant discipline.
• Experience (2-5 years) of work related to biotech / pharmaceutical industry with focus on formulation or manufacturing processes development, technical transfer, validation and submission for biological drug products.
• Track record in resolving technical challenges in an interdisciplinary team.
• Solid understanding of quality standards and regulations in pharmaceutical industry. Experience in GMP environment is an advantage.
• Proficient in development concepts and quality principles such as quality by design as well as interest in using innovative tools to inform and speed up product development. Challenging the status quo based on scientific rationale and results.
• Team spirit, interdisciplinary thinking and proven ability to work in cross-functional international teams.
• Ready to deliver in time and able to manage highly focused work periods using your strong organizational skills.
• Good written and verbal communication skills, stakeholder management.
• Strong scientific/technical writing and presentation skills.
• Open, curious, problem-solving mindset with interest in working in a dynamic environment requiring flexibility and continuous learning.
• Knowledge in data science and statistical data analysis, and background/interest in process modeling, simulation, automation and basic programming (e.g. Phyton) is an advantage.
• Excellent English required (oral & written)

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 €65,605.54a 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