Product Steward

AT33 (FCRS = AT033) Novartis Pharmaceutical Manufacturing GmbH; Österreich; On-site; EUR 67,000 - 113,000; Full time

Benefits offered by this job

Incentive program

Pension scheme

Childcare facilities

Learning and development opportunities

Worldwide career possibilities

Job summary

Novartis Pharmaceutical Manufacturing GmbH in Austria seeks a Product Steward responsible for owning process knowledge across the commercial lifecycle. You will support process control, CQAs, CPPs, and CMAs, and collaborate on product transfers, validations and regulatory submissions. Fluency in English and German is required, with 5+ years in GMP settings.

Qualifications

• Master’s degree in a relevant scientific discipline.
• Minimum 5 years of GMP manufacturing, late-stage development and/or QA/QC experience.
• Strong understanding of upstream/downstream bioprocessing technologies and related production processes.

Responsibilities

• Maintain end-to-end process knowledge of drug substance manufacturing across the lifecycle as SPOC from tech transfer through commercialization.
• Support development, maintenance and improvement of the process control strategy based on CQAs, CPPs and CMAs.
• Provide data and support for product transfer activities and CAPAs; assist validation planning and regulatory submissions.

Skills

GMP compliance

Bioprocessing

Data analysis

English

German

Education

MSc in Biotechnology, Chemistry, Pharmacy, Chemical Engineering, or related

Tools

SAP

Minitab

JMP

MS Office

Job description

Salary

Salary Range: €66,918.00 - €112,600.00 Band Level 4

Job Description Summary

We are currently seeking a passionate and skilled individual for the role of Product Steward. 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.

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.

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.

Contract & working hours

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

Diversity & inclusion

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.

Other information

In the context of China Cross-Border Data Transfer (CBDT) policy, if you need to apply for a position in China, please go to the local Recruiting System TaleNov .