Associate Lead I - Biomanufacturing, Compliance
Core
Ensuring cGMP compliance and executing quality controls for clinical and commercial biologics production in a biomanufacturing facility.
Role type
Associate Lead I, Biomanufacturing Compliance
Builds
Clinical and commercial biologics batches (mammalian cell lines, mRNA, molecular therapeutics)
Domain
Biopharmaceuticals / Biomanufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP principles application, deviation investigation, CAPA management, SOP authoring, quality system proficiency, data logbook review, internal audit participation, process compliance culture initiatives
Preferred skills
STEM background, experience with TrackWise/ComplianceWire/JD Edwards/Unicorn systems, ability to learn new manufacturing processes
Technologies
TrackWise, ComplianceWire, JD Edwards, Unicorn
Responsibilities
Facilitate rapid response for deviations and root cause analysis, review logbooks for cGMP compliance, track open investigations, participate in internal audits and CAPA programs, support SOP authoring, provide on-floor manufacturing support, identify safety improvements
Seniority
Mid-level, hands-on IC