Manufacturing Representative
Core
Ensure on-time delivery and manufacture oligonucleotide APIs to specification in a GMP environment.
Role type
Manufacturing Representative (Oligonucleotide API production)
Builds
Oligonucleotide APIs
Domain
Pharmaceutical manufacturing / Biotechnology
Required skills
GMP compliance, technology transfer, scale-up, SOP writing, equipment validation, CAPA management, clean room operations, FDA-regulated environment experience
Preferred skills
Oligonucleotide synthesis, HPLC, UF, conjugation, lyophilization, lab instrument operation (spectrophotometers, conductivity meters, auto-pipettors)
Technologies
HPLC, UF, lyophilization, spectrophotometers, conductivity meters, auto-pipettors
Responsibilities
Manufacture oligonucleotide APIs in a GMP environment; participate in technology transfer and scale-up of manufacturing processes; write and revise standard operating procedures; validate new equipment and facilities with Validation and Engineering; resolve manufacturing problems and draft quality documentation (CAPA, deviation, change control); maintain, calibrate, and troubleshoot critical process equipment.
Seniority
Entry-level to Mid-level, hands-on IC
