Technical Operations Associate
Core
Support technical activities for commercial API and drug product manufacturing across the CMO network, including investigations, change controls, and CAPAs.
Role type
Technical Operations Associate (Pharmaceutical Manufacturing)
Builds
Commercial drug products via CMO network
Domain
Pharmaceutical / Life Sciences
Required skills
Pharmaceutical manufacturing processes (tablet compression, granulation, coating, encapsulation, lyophilisation, solution/suspension manufacturing), ICH guidelines, deviation investigations, change controls, CAPA management, vendor management, data trending, risk assessments
Preferred skills
Analytical QC method development, validation, Lean Six Sigma, Quality by Design, statistical knowledge
Technologies
CMO network, manufacturing equipment
Responsibilities
Support investigations, change controls, and CAPAs; build relationships with third-party vendors; support manufacturing improvement projects; execute tasks following SOPs; contribute to data trending and risk assessments.
Seniority
Associate level
