Senior Technical Specialist, MM (MFG)
Core
Develop and manage GMP manufacturing documentation (MBRs, SOPs, CRs) and lead technical investigations to ensure operational readiness and manufacturing excellence.
Role type
Senior Technical Specialist (Manufacturing)
Builds
Manufacturing documentation, operational readiness packages, and CAPA/deviation resolutions for biopharmaceutical process campaigns.
Domain
Biopharmaceutical manufacturing / GMP compliance
Required skills
GMP documentation authoring, Master Batch Record (MBR) management, SOP development, deviation investigation, root cause analysis, CAPA management, change control, risk assessment, technical writing, cross-functional collaboration, data integrity
Preferred skills
Biopharmaceutical manufacturing experience, MSAT knowledge, mentoring, continuous improvement, regulatory inspection support
Technologies
GMP systems, LIMS, QMS
Responsibilities
Lead development and lifecycle management of Master Batch Records and SOPs; Coordinate operational readiness activities including pre-campaign training and equipment qualification; Lead complex manufacturing investigations including deviations and root cause analyses; Support manufacturing operations with change controls and audit preparation; Collaborate with cross-functional teams to ensure regulatory compliance; Drive continuous improvement initiatives and mentor junior team members.
Seniority
Senior, hands-on IC