Manufacturing Representative

Role: Manufacturing Representative focused on oligonucleotide API production in a GMP environment, supporting scale-up, technology transfer, and process validation. Responsibilities include reviewing formulation documents, scheduling resources, maintaining equipment, drafting SOPs, and collaborating with Validation and Quality teams to resolve manufacturing issues. The role requires active involvement in process validation, equipment calibration, troubleshooting, and documentation, ensuring compliance with regulatory standards. Qualifications: Bachelor's degree in a related field or equivalent; 1+ years in pharmaceutical manufacturing; familiarity with oligonucleotide synthesis, HPLC, conjugation, and lyophilization preferred. Experience working in FDA-regulated, clean room environments is highly advantageous. The position offers a day shift schedule (4:30 am - 5:00 pm) with a rotating Pitman schedule, no travel required. High-Value: focus on GMP oligonucleotide manufacturing, process scale-up, validation, and regulatory compliance in a biotech/pharma setting.