Associate Lead I - Biomanufacturing, Compliance
On-site
Core
Ensures compliance with cGMP, regulatory, and client requirements in biologics manufacturing operations.
Role type
Associate Lead I - Biomanufacturing, Compliance
Builds
Biologics drug substance for clinical production (50-4,000 liters)
Domain
Biopharmaceuticals / Biologics Manufacturing
Required skills
cGMP principles, deviation investigations, CAPA, SOP authoring, data review, training support, root cause analysis
Preferred skills
GMP experience in manufacturing or quality
Technologies
TrackWise, ComplianceWire, JD Edwards, Unicorn
Responsibilities
Facilitate rapid response for deviations, review logbooks for cGMP compliance, participate in internal audits, support SOP authoring, identify safety improvements, assist with training needs
Seniority
Entry-level to Mid-level, hands-on IC