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 compliance, technical writing, root cause analysis, CAPA management, change control, data integrity, cross-functional collaboration, mentoring
Preferred skills
None stated
Technologies
None stated
Responsibilities
Lead development and lifecycle management of Master Batch Records, SOPs, and risk assessments; Coordinate operational readiness activities including pre-campaign training and equipment qualification; Lead complex manufacturing investigations including deviations and trend analyses; Support manufacturing operations with audit preparation and technical assessments; Collaborate with cross-functional teams to ensure regulatory compliance; Drive continuous improvement initiatives and mentor junior team members
Seniority
Senior, hands-on IC