Senior Technical Specialist, MM (MFG)
Core
Develop and manage GMP manufacturing documentation, support technology transfers, and lead complex technical investigations to ensure manufacturing excellence.
Role type
Senior Technical Specialist (Manufacturing)
Builds
Manufacturing operations, technology transfers, and process campaigns
Domain
Biopharmaceutical manufacturing
Required skills
GMP expertise, technical writing, deviation investigation, root cause analysis, CAPA management, change control, data integrity, cross-functional collaboration, mentoring
Preferred skills
Chemical/Biochemical Engineering background, biopharmaceutical manufacturing experience, risk assessment, audit preparation
Technologies
Master Batch Records (MBRs), Standard Operating Procedures (SOPs), Change Requests (CRs)
Responsibilities
Lead development and lifecycle management of GMP documentation; coordinate operational readiness activities; lead complex manufacturing investigations and CAPA development; support manufacturing operations and audit preparation; collaborate with cross-functional teams; drive continuous improvement initiatives.
Seniority
Senior, hands-on IC
