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
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP expertise, technical writing, root cause analysis, CAPA management, risk assessment, data integrity, process engineering
Preferred skills
mentoring, cross-functional project leadership, continuous improvement, stakeholder influence
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 deviations; support manufacturing operations and audit preparations; drive continuous improvement initiatives; provide technical expertise during customer interactions and regulatory inspections
Seniority
Senior, hands-on IC