Summary
Location: Schaftenau, Austria
About the role:
As a Senior Expert in the Method Development Team in Process Analytical Sciences (PAS), you will be responsible for physical chemical method development, optimization, and robustness testing in late-phase pharmaceutical drug development. We work with state-of-the-art technologies to develop methods for new biopharmaceutical entities by applying scientific expertise to enable Drug Substance (DS) and Drug Product (DP) process development within a multidisciplinary project team. We are seeking an experienced scientist with strong analytical expertise, proficiency in data and digital tools, and deep knowledge of DS and DP process development.
The role will be a mix of experimental laboratory development work and authoring documentation. As such, the ideal candidate should be comfortable working in a hybrid environment both in and out of the laboratory.
Join our Analytical Development team in Schaftenau and help shape the future of healthcare. Let’s continue to build on our momentum — and make an extraordinary impact, together.
About the Role
Key Responsibilities:
- Plan, organize, perform and document physical chemical method development, e.g., HPLC and CE, in compliance with internal quality standards and HSE requirements.
- Knowledge and experience with various software tools, e.g., chromatographic or statistical software to increase efficiency.
- Support the implementation, handover and transfer of analytical methods to internal teams and external partners (e.g., CROs).
- Collaborate with internal development (PAS) laboratories, Analytical Experts (AE), and cross-functional teams to ensure seamless execution of analytical workflows.
- Design and execute physicochemical analytical approaches for DS, DP and process intermediates ensuring compliance with Quality by Design principles.
- Interpret and contextualize analytical results and apply data and digital solutions to increase efficiency. Lead or support root cause investigations and issue resolution.
- Author and review scientific reports, e.g., method development reports, support regulatory submissions, and act as analytical expert during audits and inspections.
- Manage multiple priorities, proactively communicate challenges, and resolve complex issues.
- Promote knowledge sharing, present results internally, and contribute to publications, presentations, and patents.
- Evaluate new analytical technologies, develop innovative methods (applying DoE principles), and ensure alignment with scientific standards. Contribute to ongoing digitalization efforts and apply data and digital solutions to increase quality and efficiency.
Essential Requirements:
- University degree in pharmaceutical technology, biotechnology, biochemistry, chemistry, chemical engineering, or other relevant natural science discipline.
- At least 3 years (PhD) or 6 years (MSc) of working experience in the (bio)pharmaceutical industry.
- Advanced knowledge within the area of Analytical Development.
- Expertise in Biologics DS and DP process development applying QbD principles.
- Excellent collaboration skills (ability to effectively work with others to achieve common goals through communication, teamwork, and problem-solving).
- Proficiency in oral and written English; German is beneficial.
- Strong proficiency in digital technologies.
You’ll receive:
You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards
In addition to a market-competitive base salary, we offer an attractive incentive program, a modern company pension scheme, childcare facilities, learning and development opportunities as well as worldwide career possibilities 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 € 65,605.54 a year (on a full-time basis). The actual salary will be significantly higher, as we strive to maintain a competitive position in the market and consider your previous experience, qualifications and individual competencies.
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive working environment and diverse teams, representative of the patients and communities we serve.
Adjustments for Applicants with Disabilities
If because of a medical condition, physical disability or a neurodiverse condition you require an adjustment during the recruitment process, please reach out to disabilities.austria@novartis.com and let us know the nature of your request as well as your contact information. The support which we can provide will include advice on suitable positions as well as guidance at all stages of the application process. Austrian law provides candidates the opportunity to involve the local disability representative, Behindertenvertrauensperson (BVP), in the application process. If you would like to request this, please let us know in advance as a note on your CV.
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
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
Adjustments for Applicants with Disabilities
If because of a medical condition, physical disability or a neurodiverse condition you require an adjustment during the recruitment process, please reach out to [email protected] and let us know the nature of your request as well as your contact information. The support which we can provide will include advice on suitable positions as well as guidance at all stages of the application process. Austrian law provides candidates the opportunity to involve the local disability representative, Behindertenvertrauensperson (BVP), in the application process. If you would like to request this, please let us know in advance as a note on your CV.
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
