Manufacturing Representative - Night Shift
Core
Commission, qualify, and validate new manufacturing equipment and systems while producing oligonucleotide APIs in a GMP-regulated environment.
Role type
Manufacturing Associate (Startup/Commissioning)
Builds
Oligonucleotide APIs and validated manufacturing systems
Domain
Pharmaceutical manufacturing / Oligonucleotide synthesis
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP manufacturing operations, equipment commissioning and validation, process scale-up support, SOP writing and compliance, lab instrument operation, troubleshooting, documentation management
Preferred skills
Oligonucleotide synthesis knowledge, HPLC operation, UFDF and lyophilization experience, clean room environment experience, chemical processing facility experience
Technologies
HPLC, UFDF, lyophilization, spectrophotometers, conductivity meters, auto-pipettors
Responsibilities
Support commissioning, qualification, and validation (CQV) of new manufacturing equipment and systems; Manufacture oligonucleotide APIs in a GMP-regulated environment; Assist with tech-transfer and scale-up of new processes; Operate and maintain lab instruments; Write and revise SOPs and other documentation; Collaborate with Engineering, Validation, and Quality teams to resolve technical issues; Maintain, calibrate, and troubleshoot critical process equipment
Seniority
Entry-level to Mid-level, hands-on IC