Manufacturing Associate II, Drug Substance Operations
Core
Execute manufacturing unit operations for mRNA and LMX/LNP drug substances in a GMP-regulated clean-room environment.
Role type
Manufacturing Associate II (Drug Substance Operations)
Builds
Clinical pipeline products and commercial seasonal vaccines
Domain
Biopharma / mRNA therapeutics
Deliverable
physical/clinical work
Required skills
GMP compliance, aseptic processing, chromatography, filtration, nano-mixing, data integrity, SOP execution, equipment troubleshooting
Preferred skills
STEM degree, understanding of GMP regulations
Technologies
SAP, VEEVA, Delta V, Syncade, LIMS, CMMS
Responsibilities
Execute unit operations (aseptic processing, filling, dispensing), maintain clean-room environments, perform on-the-job training, utilize manufacturing support systems, adhere to safety and documentation practices
Seniority
Mid-level, hands-on IC