Downstream Manufacturing Associate (3rd Shift)

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.