Lead Biopharma Process Steward for Contract Manufacturing

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

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