About this role
Salary Range:
60.978,00 € - 89.300,00 €
Job Description Summary
#LI-Hybrid
Location: Kundl, Austria
At Novartis, we are reimagining medicine to improve and extend people's lives. As a Process Expert at the Nucleic Acid Facilities (NAF), you will play a critical role in establishing and operating next-generation manufacturing processes for plasmid DNA, mRNA, and lipid nanoparticle (LNP) technologies. You will combine technical expertise, GMP compliance, and cross-functional collaboration to ensure reliable and efficient manufacturing of innovative therapies for patients worldwide.
As part of the Nucleic Acid Manufacturing organization in Kundl, you will serve as a process expert supporting manufacturing operations across the product lifecycle, from technology transfer and process validation through routine commercial production and continuous improvement.
You will work in close partnership with Manufacturing, MS&T, QA, QC, Engineering, Supply Chain, and external partners to drive process robustness, operational excellence, and regulatory compliance.
Job Description
Key Responsibilities:
- Serve as the process owner and technical expert for nucleic acid manufacturing processes.
- Provide real-time technical support to GMP manufacturing operations and shopfloor teams.
- Analyze process performance data to identify trends, risks, and improvement opportunities.
- Lead or support investigations, root cause analyses, CAPA implementation, and change controls.
- Author and maintain GMP documentation including SOPs, manufacturing instructions, risk assessments, and technical reports.
- Support process validation, process qualification, and Continued Process Verification activities.
- Drive operational excellence initiatives focused on safety, quality, compliance, delivery, and cost.
- Collaborate with cross-functional teams to implement process improvements and technology transfers.
- Support health authority inspections and internal audits.
- Train and coach manufacturing personnel on process-related topics.
Essential Requirements:
- Degree in Biotechnology, Biochemistry, Chemical Engineering, Pharmaceutical Sciences, Life Sciences, or a related field.
- Experience within a GMP-regulated pharmaceutical, biotechnology, biologics, vaccine, or nucleic acid manufacturing environment.
- Strong understanding of pharmaceutical manufacturing processes and process lifecycle management.
- Experience with deviation management, CAPAs, risk assessments, and change control systems.
- Solid analytical and problem-solving skills with the ability to interpret manufacturing data and trends.
- Excellent communication and stakeholder management capabilities.
- Fluency in German and English.
Desirable Requirements:
- Experience with plasmid DNA, mRNA, LNP, or biopharmaceutical manufacturing processes.
- Knowledge of process validation, technology transfer, and process characterization.
- Experience with GMP systems such as SAP, MES, eQMS, and electronic documentation systems.
- Knowledge of EU GMP requirements and data integrity principles.
Please submit your application documents, including your CV, in both German and English .
Benefits & Rewards
At Novartis, we’re committed to reimagining medicine together - and rewarding the people who make it happen.
Expected Annual Base Salary Range for role: € 60.978,00 do € 89.300,00
The base salary offered is determined based on gender-neutral objectives, such as relevant skills, competencies and experience in accordance with the Novartis pay setting policy and upon joining Novartis will be reviewed periodically.
In addition to your base salary, you may be eligible for a performance-based bonus depending on certain performance parameters.
The rewards of being part of our team go far beyond base pay and incentives. We also offer a variety of competitive benefits in kind to help you thrive personally and professionally, such as insurance plans, retirement plans, wellbeing resources and global recognition programs. In addition, we provide flexible and hybrid working options, where possible, and minimum 14 weeks paid parental leave.
Pay equity is a fundamental principle of our employment policy and reflects our commitment to create a diverse, equitable and inclusive environment that treats all employees with dignity and respect, as outlined in our Code of Ethics.
Read our brochure to learn more about our global total rewards offering: https://www.novartis.com/sites/novartis_com/files/novartis-life-handbook.pdf
Note: Benefits and compensation may vary by country and are subject to local legal requirements, including provisions of collective bargaining agreements where applicable. A full overview of your compensation package, including any relevant collective bargaining agreement details applicable to your role based on your employment location and Novartis employer entity, will be communicated separately to you during the application process.
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 € 60.977,70 /year (on a full time basis). We also offer a potential market oriented excess payment in line with your experience and qualifications.
Accessibility and accommodation
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.
Commitment to Diversity and Inclusion
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Skills Desired
Data Analytics