In this critical position, you will own the process knowledge of our products throughout their commercial lifecycle, ensuring continuously improving processes.

Your expertise will be vital in maintaining seamless knowledge flow across functions and sites, providing technical and scientific process support.

Job Description

Major accountabilities:

Maintain oversight and end-to-end process knowledge of the drug substance manufacturing process across the entire commercial lifecycle, acting as the single point of contact (SPOC) from technology transfer through commercialization.

Support the development, maintenance, and continuous improvement of the process control strategy, based on Critical Quality Attributes (CQAs), Critical Process Parameters (CPPs), and Critical Material Attributes (CMAs).

Monitor and evaluate critical and key process variables through statistical analysis and regular product-specific trending activities (e.g., Ongoing Process Verification (OPV), Annual Product Quality Reviews (APQR)), and communicate insights at site level.

Provide technical and process data required for product transfer activities, including the definition and execution of necessary studies.

Support Process Experts in troubleshooting activities, root cause investigations, and the implementation of Corrective and Preventive Actions (CAPAs).

Support Validation Leads and Process Experts in planning and assessing process validation activities, including evaluation of re-validation requirements.

Contribute to product registration strategies and support regulatory submissions, lifecycle management activities, and site inspections.

Essential requirements:

Master’s degree (MSc) in Biotechnology, Chemistry, Pharmacy, Chemical Engineering, or a related scientific discipline.

Minimum 5 years of experience in GMP manufacturing, late-stage development and/or QA/QC within the relevant area of expertise.

Strong understanding of upstream and downstream bioprocessing technologies, including cell culture cultivation, chromatographic separation, filtration, and related manufacturing processes.

Proven experience with computerized systems and data analysis tools, including MS Office, SAP, Minitab, JMP, and other relevant applications.

Sound knowledge of regulatory requirements and industry guidelines, including GMP and ICH quality standards.

Fluent in English and German, with strong written and verbal communication skills.

For this role, we offer a temporary contract of 2 years.

Rewards

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 €66,918.00 /year (on a full time basis).

We also offer a potential market oriented excess payment in line with your experience and qualifications.

The 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. Further details will be provided during the application process.

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.

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.

Commitment to Diversity and Inclusion / EEO paragraph:

Novartis is committed to building an outstanding, inclusive work environment and diverse teams’ representative of the patients and communities we serve.

Skills Desired

Applied Statistics, Manufacturing Production, Manufacturing Technologies, Operational Excellence, Process Control, Quality Compliance, Regulatory Compliance, Technical Leadership, Technology Transfer