Contract Manufacturing - Product Stewardship

Novartis; Österreich; On-site; EUR 82,000 - 152,000; Full time

Benefits offered by this job

Insurance plans

Retirement plans

Wellbeing resources

Global recognition programs

Flexible working options

Parental leave (14 weeks)

Job summary

Novartis in Austria seeks an accountable technical/scientific steward for drug substance programs. You will own external-customer processes, ensure robust manufacturing, lifecycle knowledge, and ongoing validation, while serving as the technical SPOC between manufacturing and CMO customers.

You will monitor process performance with statistics, OPV, and quality indicators, assess changes for regulatory impact, manage risk and costs, and drive timely improvements through cross-functional

Qualifications

• MSc/PhD in biotech/pharma related field.
• 9+ years in biopharma drug substance manufacturing or MS&T.
• Strong understanding of biotechnology processes (fermentation, downstream, GMP).
• Experience with computerized systems and data handling (MS Office, SAP, Minitab).
• Good commercial awareness linking technical work to contracts and supply.
• Proven ability to resolve complex issues and drive timely decisions.

Responsibilities

• Maintain end-to-end scientific ownership of external-customer drug substance processes within the Novartis Contract Manufacturing network.
• Monitor process and product performance using statistics, OPV, and quality indicators; translate trends into customer updates and actions.
• Evaluate customer- or Novartis-initiated process changes for regulatory impact, feasibility, batch needs, risks, timelines and costs.
• Track customer commitments and manufacturing performance; ensure timely CAPA implementation in line with Quality Agreements.
• Lead or support root cause investigations and cross-functional product improvement initiatives.
• Design and manage customer-funded or jointly agreed optimization projects with defined scope and timelines.
• Lead and support technology transfers of biological drug substances into Novartis sites.
• Ensure knowledge flow between customer, governance, and site functions.
• Represent MS&T/Product Stewardship in governance meetings.

Skills

Biotech processes

Data analysis

Problem solving

Commercial awareness

Customer-facing

Leadership

MS Office

SAP

Education

MSc or PhD in Biotechnology, Biochemistry, Chemical Engineering, Pharmaceutical Technology or equivalent

Tools

Minitab

SAP

Job description

Salary Range:

€81,600.00 - €151,500.00

Job Description Summary

Accountable technical/scientific steward for assigned Drug Substance products, ensuring robust processes, lifecycle knowledge, continued validation, technical problem solving and an effective scientific interface between manufacturing and CMO customers.

Job Description

Major accountabilities:

• Maintain end-to-end scientific and technical ownership of assigned external-customer drug substance processes manufactured within the Novartis Contract Manufacturing network; act as the Novartis technical SPOC for the customer.
• Monitor process and product performance using statistical analysis, ongoing process verification (OPV), and agreed technical and quality indicators; translate trends into clear customer updates and actions.
• Evaluate customer- or Novartis-initiated process and technical changes, including feasibility, regulatory impact, technical batch requirements, risks, timelines, cost implications, and business benefit.
• Track customer product commitments and manufacturing performance; identify issues early and ensure timely implementation of corrective and preventive actions in alignment with Quality Agreements and contractual responsibilities
• Lead or support joint root cause investigations and cross-functional product improvement initiatives.
• Design and manage customer-funded or jointly agreed optimization projects, controlling scope, deliverables, timelines, technical risks, and implementation readiness
• Lead and support technology transfers of biological drug substances into Novartis manufacturing sites.
• Ensure efficient knowledge and information flow between the customer, Novartis project governance, and site functions.
• Represent MS&T/Product Stewardship in internal and joint customer governance meetings.

Minimum Requirements

• Academic degree (MSc, PhD) in Biotechnology, Biochemistry, Chemical Engineering, Pharmaceutical Technology or equivalent.
• Total 9+ years of exp and several years of experience in biopharmaceutical drug substance manufacturing, process development, MS&T, or technical product stewardship, preferably in a contract manufacturing environment or in a customer-facing technical role.
• Proven understanding of biotechnology processes (Microbial and/or mammalian fermentation, downstream processing, GMP, regulatory aspects).
• Thorough experience in computerized systems, sound experience of data handling and fundamental understanding of applied statistics (i.e. MS-office, SAP, Minitab).
• Strong commercial awareness, including the ability to connect technical execution with contract scope, customer commitments, capacity, cost, and supply performance.
• Demonstrated ability to resolve complex technical and operational issues, drive timely decisions, manage risk, and maintain a strong customer- and delivery-focused mindset.

Rewards

At Novartis, we’re committed to reimagining medicine together - and rewarding the people who make it happen.

The rewards of being part of our team go far beyond base pay and incentives.We also offer a variety of competitive benefits inkindto help you thrive personally and professionally, such as insurance plans, retirement plans, wellbeingresourcesand global recognition programs. In addition, we provide flexible and hybrid working options, where possible, anda minimum of14 weekspaid parental leave.

Expected Annual Base Salary Range for role:

• 81,600 151,500 EUR

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.

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.

Commitment to Diversity and Inclusion / EEO paragraph:

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

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,supportingand 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.

Skills Desired

Good Manufacturing Practices (GMP)