Expert Drug Supply (Clinical Manufacturing) – Hybrid

About the role

Novartis Slovenia is looking for an Expert Drug Supply to join its Clinical Manufacturing Operations (Cx MO) team at the Clinical Manufacturing site in Mengeš, Slovenia. The role supports the manufacturing process through environmental monitoring of cleanrooms, product change-over and compliance with regulations, internal procedures and GxP requirements. The position is listed as hybrid.

Key responsibilities

• Create effective, widely applicable procedures and drive their implementation
• Build and maintain a network inside and outside the organisation for knowledge sharing and best practices, and act as a bridge between partners and customers
• Drive change management: communicate, solve key challenges such as deviations and unexpected results, and lead the transfer of know-how to other departments or external contractors, including on-site training
• Support the development of a process-oriented, inclusive culture and represent the team in relevant meetings
• Interact with health authorities and act as a technical expert in internal (e.g. GGA) and external (e.g. JAZMP) audits
• Independently plan, run, supervise and document Cx MO activities such as sampling of clean utilities, environmental monitoring, cleaning, personnel and material flow certification and documentation reviews
• Prepare, issue, complete and archive documentation (logs, forms, batch records) and review data prepared by others
• Propose and implement improvements, new methods or technologies, and provide scientific and technical advice

Required profile

• Bachelor's degree or equivalent in Pharmacy, Biotechnology, Chemistry, Microbiology or a related field
• At least 3 years of directly related experience as a biologics manufacturing expert
• Fluent Slovenian and technical English
• Knowledge of GxP and the assigned Cx MO environment (cleanrooms, personnel and material flows)
• Preferred: experience resolving GxP deviations and managing GxP changes, and experience giving evidence in internal and/or external audits

Required skills

• Microsoft Office and other computer software
• GxP knowledge

Successful candidates will be offered a permanent employment contract with a 6-month probation period. Applications should be submitted with a CV in Slovenian and English.