Manufacturing Associate II

Overview Piper Health and Sciences is seeking a skilled and motivated Manufacturing Associate II (Downstream) to join a biopharmaceutical company in the Gaithersburg, MD area. The Manufacturing Associate II is a crucial role in supporting the downstream manufacturing team. This position involves operating and maintaining downstream processing equipment, performing filtration and chromatography techniques and supporting production activities in a cleanroom environment. Responsibilities Execute manufacturing of drug product following GMP guidelines Perform buffer and media preparation for downstream processing Operate and maintain chromatography systems for protein purification Conduct tangential flow filtration (TFF) and viral filtration to ensure product purity Perform aseptic processing in a clean room environment, adhering to strict contamination control measures Maintain accurate documentation of manufacturing activities in compliance with GMP regulations Troubleshoot and resolve issues related to downstream processing equipment Qualifications 3+ years of professional experience working in a GMP environment (Biotechnology or Pharmaceutical organization) with 1+ years of experience working in downstream manufacturing Experience performing chromatography, filtration techniques, aseptic processing, TFF (tangential flow filtration) Experience demonstrating aseptic technique and ability to work in a BSC (biological safety cabinet) Understanding of cGMP (current Good Manufacturing Practices) Bachelor's degree in science related field Compensation Salary: $60,000 - $75,000 annually, commensurate with experience Comprehensive Benefits: Medical, Dental, Vision (through Cigna), 401k, Sick leave required as by law, PTO, Holidays Additional Information This job opens for applications on 08/22/2025. Applications for this job will be accepted for at least 30 days from the posting date. Keywords: Manufacturing, manufacturing associate, GMP, good manufacturing practice, cGMP, current good manufacturing practice, TFF, filtration, downstream manufacturing, upstream manufacturing, central service, chromatography skids, process development, facilities, biological safety cabinet, BSC, FDA, biotech, biotechnology, pharmaceutical, pharma, biopharmaceutical, QC, quality control, batch record, SOP, standard operating procedure, log book, equipment calibration, equipment maintenance, autoclave, solution prep, buffer, reagent, sanitize, filter, cell culture, fill finish, column packing, skids, manufacturing, MFG, manufacturing specialist, biopharmaceutical associate, bioprocess associate, manufacturing technical associate, cell therapy, downstream, upstream, Allstream, support service, central service, all stream, cleanroom

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