Product Steward (m/f/d) – Product Technology Expert

About the role

Join Novartis' MS&T DS Bioproduction team in Mengeš to act as the product and process expert for biologic drug substances throughout their commercial lifecycle. You will drive data‑based decisions, support lifecycle management and ensure robust, compliant manufacturing.

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 and support for biologics manufacturing processes, including technical documentation and validation activities.
• Lead investigations, root‑cause analyses and implement corrective and preventive actions (CAPA).
• Assess technical changes for impact on product quality, process performance and regulatory compliance.
• Collaborate with cross‑functional teams on lifecycle management, regulatory activities and inspection readiness.

Required profile

• University degree in biotechnology, pharmacy, chemistry, chemical engineering or related field.
• Minimum five years of experience in biologics or pharmaceutical manufacturing.
• Strong knowledge of upstream and downstream bioprocess technologies and GMP requirements.
• Experience with technical documentation, validation and product lifecycle management.
• Excellent communication and stakeholder‑management skills in a global, cross‑functional environment.

Required skills

• Upstream and downstream bioprocessing expertise.
• Statistical analysis and data‑trend evaluation.
• Technical documentation and validation procedures.
• Good Manufacturing Practice (GMP) and regulatory compliance.
• Root‑cause analysis and CAPA implementation.

What we offer

• Annual base salary €32,060 – €59,540, plus 12% annual bonus.
• Additional benefits such as holiday bonus, performance award, voluntary pension, comprehensive insurance and wellbeing programs.
• Opportunities for continuous learning and career development within a global pharmaceutical leader.