Job Description Summary
Location: Schaftenau, Austria #onsite
Role Purpose:
As a Senior Analytical Expert (AE), you will lead analytical project activities and apply excellent scientific expertise to enable Drug Substance (DS) and Drug Product (DP) process development within a multidisciplinary project team developing new biological drugs. 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 ideal candidate will also bring solid project management skills to drive efficient collaboration with internal teams and external partners, supporting our late-phase project portfolio.
Job Description
Key Responsibilities:
- Serve as matrix leader within the process analytical sub-team, driving design, supervision, and coordination of analytical development activities for assigned projects.
- Establish physicochemical analytical strategies according to Quality by Design principles for DS, DP, and process intermediates and guide matrix teams scientifically.
- Interpret and contextualize analytical results and apply data and digital solutions to increase efficiency. Lead or support root cause investigations and issue resolution.
- Monitor project progress, represent analytical aspects in sub-team meetings, and provide expert input.
- Oversee in-house and outsourced analytical work, ensuring timelines and deliverables are met.
- Author and review scientific reports, support regulatory submissions, and act as analytical expert during audits and inspections.
- Manage multiple priorities, proactively communicate challenges, and resolve complex issues.
- Contribute to budget and resource planning, maintain cost awareness, and manage timelines.
- Build strong stakeholder relationships with internal teams and external partners (e.g., CROs).
- Promote knowledge sharing, present results internally, and contribute to publications, presentations, and patents.
- Evaluate new analytical technologies, develop innovative methods, and ensure alignment with scientific standards. Contribute to ongoing digitalization efforts and apply data and digital solutions to increase efficiency.
- Respond to analytical queries during audits and regulatory reviews; ensure data integrity in CMC modules.
What You Will Bring to the Role:
- 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.
- Solid project management skills.
- 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.
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.
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/year (on a full time basis). In most cases, the actual salary will be higher, as we strive to maintain a competitive position in the market and consider your previous experience, qualifications and individual competencies
Skills Desired