Mfg Operations Associate Director - Biologics, Drug Substance
Core
Technical leader for biologics drug substance manufacturing execution at external CDMO partners, ensuring process compliance, supply reliability, and rapid issue resolution.
Role type
Senior IC/Lead manufacturing operations manager (biologics)
Builds
Reliable supply of biologics drug substance
Domain
Biopharmaceuticals / Biologics manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
biologics drug substance manufacturing, cGMP operations, deviation management, real-time troubleshooting, batch record management, change control, aseptic manufacturing, cross-functional coordination, project management, process improvement
Preferred skills
external manufacturing partner experience, leadership of technical teams, shift work flexibility, international travel
Technologies
cGMP systems, batch record systems, deviation management tools
Responsibilities
Provide technical leadership for drug substance manufacturing campaigns at external partners; oversee triage and resolution of execution-related deviations; lead cross-functional coordination across MSAT, Quality, and manufacturing teams; drive improvements in yield, cycle time, and manufacturing reliability; oversee implementation of approved process changes; build and strengthen Technical Services capability within biologics.
Seniority
Senior, hands-on IC with leadership responsibilities
