Knowledge of aseptic and non-aseptic manufacturing
Proficiency in root cause analysis and investigations
The role bridges the gap between life-changing therapies and patients by providing technical support for global biopharma companies
Job Summary
The role bridges the gap between life-changing therapies and patients by providing technical support for global biopharma companies.
Incumbents are responsible for managing technical transfers, developing batch records, and leading complex quality investigations within a GMP environment.
The position requires strong problem-solving abilities to resolve manufacturing issues while ensuring strict adherence to regulatory guidelines and safety protocols.
Matching Summary
The role bridges the gap between life-changing therapies and patients by providing technical support for global biopharma companies.
Skills & Requirements
Must-have
3+ years GMP experience in regulated industry
Knowledge of aseptic and non-aseptic manufacturing
Proficiency in root cause analysis and investigations
Experience authoring batch records and SOPs
Strong technical writing skills for cGMP documentation
Nice-to-have
Clean room aseptic experience
Familiarity with Quality Deviation Management Systems