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Downstream Manufacturing Associate

Negotiable Salary

Pharma Universe

Chicago, IL, USA

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Manufacturing Associate – Downstream (3rd Shift) Location: Chicago, IL An established biopharmaceutical manufacturer is seeking a Manufacturing Associate II to join their downstream processing team on 3rd shift. This role plays a critical part in supporting the production of biologics for both clinical and commercial use, with a strong focus on GMP compliance, aseptic practices, and downstream purification processes. Key Responsibilities: Carry out manufacturing activities in line with SOPs, batch records, and production schedules, with minimal supervision. Responsibilities include: Preparation and handling of buffers and process solutions Operation of filtration systems, including dead-end, depth, and tangential flow filtration (TFF) Setup and execution of chromatography processes Aseptic final filtration of intermediates and drug substances Monitoring process parameters using HMI/PLC systems and performing in-process tests (pH, conductivity, spectroscopy) Assist with equipment troubleshooting and process deviations Support training of new team members as needed Accurately complete documentation in accordance with cGMP standards Maintain cleanliness of manufacturing areas and equipment following scheduled cleaning routines Handle raw materials, verify inventory, and perform data entry into MES systems Adhere to all safety protocols, reporting any incidents or quality concerns to supervisors Qualifications: Associate degree or higher in Biotechnology, Biology, Chemistry, or related field preferred Alternatively, 2–4 years of hands-on industry experience in downstream manufacturing Prior experience in GMP-regulated cleanroom environments is highly preferred Key Skills: Strong knowledge of downstream processes including TFF, chromatography, and filtration systems Familiarity with GMP documentation practices and cleanroom procedures Comfortable working independently or as part of a team in a fast-paced manufacturing setting Proficiency in manufacturing systems (e.g., SAP, LIMS, DeltaV, MES) is an advantage Ability to communicate effectively and follow complex instructions This is a great opportunity for someone looking to build on their experience in downstream biologics manufacturing and contribute to a high-performing production environment.

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Chicago, IL, USA
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