Manufacturing Representative

Role: Manufacturing Representative overseeing GMP oligonucleotide API production, focusing on process execution, technology transfer, and quality compliance. Responsibilities: schedule resources, review formulation and active ingredient processes, write/update SOPs, validate equipment with Validation and Engineering teams, troubleshoot equipment, and address manufacturing issues through CAPA, deviation, and change control documentation. Qualifications: Bachelor's degree in a related field or equivalent, 1+ years of pharmaceutical manufacturing experience, familiarity with oligonucleotide synthesis, HPLC, UF, conjugation, and lyophilization preferred. Experience in a GMP, FDA-regulated environment, and clean room exposure advantageous. HighValue: GMP oligonucleotide API manufacturing, technology transfer, process validation, SOP development, quality documentation, biotech manufacturing, day shift, no travel required.