Manufacturing Associate I
Core
Execute hands-on manufacturing operations for mRNA drug substance production in a GMP-regulated cleanroom environment.
Role type
Entry-level manufacturing associate (drug substance operations)
Builds
mRNA drug substance batches
Domain
Biopharma / mRNA therapeutics
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP compliance, aseptic processing, cleanroom operations, batch record execution, data integrity documentation, equipment operation, safety procedures
Preferred skills
STEM background, attention to detail, disciplined execution, continuous improvement mindset, technical process learning
Technologies
SAP, Veeva, DeltaV, Syncade, LIMS, CMMS
Responsibilities
Execute manufacturing operations following approved procedures and batch records; Perform cleanroom operations with focus on consistency; Support drug substance activities including aseptic processing, formulation, filtration, mixing, filling, and dispensing; Complete real-time documentation adhering to data integrity standards; Maintain production area cleanliness and readiness; Follow safety and waste handling procedures; Use manufacturing systems and equipment; Complete required training and maintain qualifications.
Seniority
Entry-level, hands-on IC