Senior Associate Manufacturing
Core
Ensure commercial and clinical manufacturing processes are compliant, efficient, and continuously improving for Drug Product operations.
Role type
Senior Associate Manufacturing (Drug Product Operations)
Builds
Commercial and clinical drug product manufacturing processes
Domain
Biotechnology / Pharmaceutical Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP compliance, process validation, deviation management, change control, data analytics, root cause analysis, SOP development, batch record management
Preferred skills
Aseptic manufacturing experience, biologics manufacturing, process validation expertise, data visualization tools (Spotfire, JMP, Excel)
Technologies
CDOCs, Enterprise Data Lake, Spotfire
Responsibilities
Initiate, revise, and approve controlled manufacturing documents; Support implementation of new processes and equipment; Analyze manufacturing data to identify trends and improvement opportunities; Support investigation and resolution of manufacturing deviations; Assist in developing and executing process validation protocols; Support change control activities to ensure regulatory compliance
Seniority
Mid-level, hands-on IC