Manager*in GMP Manufacturing Compliance – Oligonukleotide (m/w/d)
Core
Ensure GMP compliance for oligonucleotide production, from startup preparation through scaling and continuous standard development.
Role type
Manager, GMP Manufacturing Compliance
Builds
Oligonucleotide therapeutic products
Domain
Life Sciences / Pharma / Oligonucleotide manufacturing
Required skills
GMP regulatory experience, risk analysis, SOP creation, change control management, audit support, deviation analysis
Preferred skills
Chemistry or Pharmacy degree, analytical thinking, organizational talent, independent work, MS Office, quality management systems
Technologies
MS Office, Quality Management Systems
Responsibilities
Prepare for production start and ensure compliant launch, scale compliance management, analyze deviations and implement corrective actions, identify risks proactively, create and review SOPs/Change Controls/Qualification documents, conduct training and audit support
Seniority
Manager, hands-on IC