Manufacturing Associate - 233994 - Medix

Job Title: Manufacturing Associate I-III

Location: Chicago, IL

Position Type: Full-time, Non-Exempt

Overview:

The Manufacturing Associate is responsible for the production of biotechnology products used in clinical and commercial human applications. This role requires proficiency in aseptic techniques while working in controlled environments, some of which require full aseptic gowning. The Manufacturing Associate II must adhere to company policies, follow FDA cGMP guidelines, and comply with all relevant government regulations.

Key Responsibilities:

• Support daily manufacturing operations, including:

• Weighing and dispensing of materials

• Operating filtration systems

• Inoculating mammalian or cytokine cells

• Conducting fermentation and harvest processes

• Operating chromatography columns and tangential flow filtration (TFF) systems

• Performing in-process testing such as pH, conductivity, spectrophotometry, osmolality, cell counts, and other relevant assays

• Preparing media and buffer solutions

• Accurately complete Batch Records and other cGMP documentation in a timely manner

• Maintain cleanliness in the manufacturing area, including the removal and disposal of contaminated materials

• Ensure manufacturing areas meet required clean room conditions at all times

• Report any deviations, nonconformances, or issues during the shift to the Supervisor

• Assist with the transfer of technology and processes from Process Development to cGMP Manufacturing

• Comply with all safety, cGMP, and company policies, practices, and procedures

• Perform additional tasks and responsibilities as required by the Supervisor

Qualifications:

• Education:

• Associate’s degree or higher in Biology, Chemistry, Biotechnology, or a related field preferred

• Experience:

• 2 to 4 years of experience in the biologics industry or a related field required

Additional Requirements:

• Strong attention to detail, organizational skills, and ability to work in a team-oriented environment

• Ability to work in controlled and classified environments, adhering to strict aseptic techniques and safety standards