Downstream Manufacturing Supervisor

We are recruiting on behalf of an innovative biotech company based in Chicago, IL, that has recently secured two FDA approvals and boasts a strong pipeline of advanced assets. As they transition from R&D to full-scale commercial operations, they are rapidly expanding their facilities, with ambitious plans to scale their manufacturing from 50L to 2000L by the end of the year and doubling their workforce within two years.

This is a fantastic opportunity to join a growing team during an exciting phase of their journey, with more approvals expected by next year and further expansion through 2030.

The Downstream Manufacturing Supervisor will play a hands-on role, overseeing the purification of mammalian cell-based cultures and producing recombinant proteins for mammalian-based biosimilars. You will manage purification processes of volumes ranging from 50L to 1000L for engineering, clinical, and commercial batches in a cGMP environment. This role requires expertise in AKTA purification skids or similar, tangential flow filtration (TFF), and knowledge of batch records, protocols, and investigations.

Key Responsibilities:

• Supervise and execute downstream processes in a cGMP environment, including column packing, troubleshooting, and data analysis.
• Provide technical leadership in the development and execution of purification processes.
• Collect and evaluate operating data to make real-time adjustments to products and equipment.
• Prepare and review quality management documents, including deviations, change controls, and investigation reports.
• Ensure timely execution of engineering and clinical batches.
• Collaborate with teams and external vendors to resolve technical issues and maintain production equipment.
• Lead compliance with GMP standards and environmental health and safety policies.
• Coordinate and oversee investigations and corrective actions for issues during batch execution.
• Continuously work to improve manufacturing techniques and establish equipment specifications.

Qualifications:

• Bachelor’s or Master’s degree in Chemical, Biological, or Biochemical Sciences.
• 5+ years of experience in biopharmaceutical manufacturing, with a strong focus on downstream purification processes.
• Prior experience working in a cGMP and aseptic environment.
• Hands-on experience with AKTA process skids or similar systems, and familiarity with single-use manufacturing consumables (bags, tube sets, columns, manifolds).
• Strong knowledge of executing engineering and clinical batches, along with familiarity with GMP documentation.

Skills & Competencies:

• Excellent interpersonal skills and ability to work independently or within a team.
• Strong communication skills—both verbal and written—with a keen eye for detail.
• Proficiency in Word, Excel, and basic computer skills.
• Experience in GMP batch manufacturing documentation, packaging, and audit/review processes.
• Knowledgeable in cleaning verification/validation.

Work Environment & Physical Demands:
This role may require flexibility with working hours, occasional travel, and the ability to work under pressure to meet deadlines.