Downstream Manufacturing Associate

Manufacturing Associate III

We are recruiting for an innovative biotech company in Chicago, IL, that is rapidly growing after securing two FDA approvals and developing a robust pipeline. As the company transitions from R&D to commercial operations, they are expanding their manufacturing capacity from 50L to 2000L by year-end and plan to double their workforce within the next two years.

We are looking for multiple Manufacturing Associates from Junior to Principal level to join their team and assist with Drug Product manufacturing processes. In this position, you will support the purification of mammalian cell-based cultures and aid in the production of recombinant proteins in a cGMP environment.

Key Responsibilities:

• Assist in daily operations by efficiently using equipment and materials to produce quality products under cGMP, following the production plan.
• Support the training of staff on equipment, processes, and Standard Operating Procedures (SOPs).
• Adhere to safe work practices and comply with external policies and EHS standards during production.
• Contribute to maintaining packaging schedules and assist in managing departmental resources.
• Participate in qualification and validation activities, as well as support process-related investigations and corrective actions.
• Help review and maintain documentation to ensure compliance with cGMPs and support operational efficiency.

Requirements

• Aseptic Processing experience preferred
• PFS and Vials manual visual inspection experience
• Finished Product packaging experience with Serialization preferred
• Previous biotech experience in a Pharma environment is proferred