Ekspert tehnologije izdelkov (m/ž/d) / Product Steward (m/f/d)
Core
Product and process expert for biologics drug substances throughout the commercial lifecycle, ensuring robust manufacturing, regulatory compliance, and reliable supply.
Role type
Senior IC manufacturing process expert (biologics)
Builds
Biologic drug substances for patients worldwide
Domain
Biopharmaceuticals / Biologics manufacturing
Required skills
biologics manufacturing processes, upstream/downstream technologies, lifecycle management, validation, root cause analysis, GMP, statistical analysis
Preferred skills
cross-functional project leadership, advanced data analytics
Technologies
upstream/downstream technologies, statistical tools
Responsibilities
Own product and process knowledge throughout the commercial biologics product lifecycle; Monitor process performance through data trending and statistical analysis; Maintain oversight of drug substance manufacturing processes; Create, review, and maintain technical, validation, and lifecycle management documentation; Lead and support investigations, root-cause analyses, and implementation of corrective and preventive actions; Assess technical changes and evaluate impacts on product quality, process performance, and compliance.
Seniority
Senior, hands-on IC