Product Steward (m/f/d)

About the role

Novartis is looking for a Product Steward I to join the MS&T DS Bioproduction team in Mengeš, Slovenia. You will be the product and process expert for biologic drug substances throughout their commercial lifecycle, driving data‑based decisions and supporting robust manufacturing, regulatory compliance and reliable supply.

Key responsibilities

• Own product and process knowledge across the commercial biologics lifecycle.
• Monitor process performance using data trending and statistical analysis to identify continuous‑improvement opportunities.
• Provide expert oversight of drug substance manufacturing and support process activities.
• Create, review and maintain technical, validation and lifecycle‑management documentation.
• Lead investigations, root‑cause analyses and implement corrective and preventive actions (CAPA).
• Assess technical changes for impact on product quality, process performance and compliance.
• Collaborate with cross‑functional teams on lifecycle management, regulatory activities and inspection readiness.
• Support introduction of new products, processes and technologies into manufacturing.
• Contribute to regulatory documentation and ensure adherence to internal and external requirements.
• Participate in operational‑excellence initiatives and knowledge‑sharing activities.

Required profile

• University degree in Biotechnology, Pharmacy, Chemistry, Chemical Engineering, Pharmaceutical Technology or related field.
• Minimum five years of experience in biologics or pharmaceutical manufacturing.
• Strong knowledge of upstream and downstream biopharmaceutical process technologies.
• Experience with technical documentation, validation activities and product lifecycle management.
• Familiarity with GMP, quality systems and regulatory guidelines.
• Excellent communication and stakeholder‑management skills in a global, cross‑functional environment.

Required skills

• Biopharmaceutical manufacturing (upstream & downstream)
• Technical documentation and validation
• Product lifecycle management
• Good Manufacturing Practice (GMP)
• Quality systems and regulatory compliance
• Statistical analysis tools

What we offer

• Annual gross salary range €32,060 – €59,540, plus a 12% annual bonus.
• Additional benefits: vacation bonus, performance award, voluntary pension scheme, accident and health insurance, specialist medical coverage, and other statutory benefits.
• Permanent contract with a six‑month probation period.