Manufacturing Representative - Night Shift
Core
Commission, qualify, and validate new oligonucleotide manufacturing equipment and systems while producing APIs in a GMP-regulated environment.
Role type
Manufacturing Associate (Oligonucleotide API production)
Builds
Oligonucleotide APIs for therapeutic development
Domain
Pharmaceutical manufacturing / Oligonucleotide synthesis
Required skills
GMP manufacturing, equipment commissioning and validation, process scale-up, SOP writing, lab instrument operation, troubleshooting, documentation compliance
Preferred skills
Oligonucleotide synthesis, HPLC, UFDF, lyophilization, clean room experience, PSM regulated environments
Technologies
HPLC, UFDF, lyophilization, spectrophotometers, conductivity meters, auto-pipettors
Responsibilities
Support CQV of new equipment, manufacture oligonucleotide APIs, assist with tech-transfer and scale-up, operate and maintain lab instruments, write and revise SOPs, collaborate with Engineering/Validation/Quality teams, maintain and calibrate critical process equipment
Seniority
Entry-level to Mid-level, hands-on IC