Downstream Manufacturing Associate

Pharma Universe; Chicago (IL); On-site; USD 50,000 - 70,000; Full time

Job summary

Pharma Universe is seeking a Manufacturing Associate II for their downstream processing team in Chicago. This critical role involves supporting the production of biologics, ensuring adherence to GMP practices and conducting aseptic processes. Ideal candidates have relevant education or hands-on industry experience, ready to contribute to a high-performing manufacturing environment.

Qualifications

• 2-4 years of hands-on industry experience in downstream manufacturing preferred.
• Prior experience in GMP-regulated cleanroom environments is highly preferred.

Responsibilities

• Perform manufacturing activities following SOPs and production schedules.
• Setup and execute chromatography processes and handle raw materials.
• Document procedures accurately in compliance with cGMP standards.

Skills

Knowledge of downstream processes

Familiarity with GMP documentation

Ability to work independently

Effective communication skills

Education

Associate degree or higher in Biotechnology, Biology, Chemistry

Tools

SAP

LIMS

DeltaV

MES

Job description

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.