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...

An industry leader in Oncology is seeking an experienced Downstream Manufacturing Supervisor to oversee biologics production processes during our PM shift. The successful candidate will be responsible for managing the operational activities related to downstream processing, ensuring adherence to Good Manufacturing Practices (GMP), and maintaining the highest quality standards in our biologics manufacturing facility.

Key Responsibilities:

• Supervise and lead a team of manufacturing technicians, ensuring alignment with production schedules and compliance with regulatory requirements.
• Oversee the execution of downstream processing steps, including filtration, chromatography, and buffer preparation.
• Manage the documentation and reporting of batch records and manufacturing activities.
• Coordinate training and development for team members to maintain competency in downstream processing techniques and safety protocols.
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Global Life Science Hub is partnered with an innovative biopharmaceutical company specializing in difficult-to-formulate biologics in the Oncology and Infectious Disease fields. Recently, the company has achieved 2 FDA approvals and is now transitioning from R&D to a full-scale commercial organization. With a highly robust pipeline of advanced assets and expected approvals lined up until 2030, the company is positioned for significant growth.

To support further expansion, we seek an on-site Downstream Manufacturing Lead in Chicago who will be responsible for leading and growing the team while executing purification on a wide range of mammalian based biologics. The ideal candidate should posses technical expertise with various chromatography methods.

Responsibilities:

• Perform and supervise downstream process at multiple scales in a cGMP environment, column packing, process troubleshooting and data analysis.
• Provides technical...

Global Life Science Hub is partnered with an innovative biopharmaceutical company specializing in difficult-to-formulate biologics in the Oncology and Infectious Disease fields. Recently, the company has achieved 2 FDA approvals and is now transitioning from R&D to a full-scale commercial organization. With a highly robust pipeline of advanced assets and expected approvals lined up until 2030, the company is positioned for significant growth.

To support further expansion, we seek a Downstream Manufacturing Lead who will be responsible for leading and growing the team while executing purification on a wide range of mammalian based biologics. The ideal candidate should posses technical expertise with various chromatography methods.

Responsibilities:

• Perform and supervise downstream process at multiple scales in a cGMP environment, column packing, process troubleshooting and data analysis.
• Provides technical direction in the...

We are recruiting a Downstream Manufacturing Supervisor for a hands-on role in the purification of mammalian cell-based cultures and production of recombinant proteins for biosimilars. The position involves handling purification volumes from 50L to 1000L for engineering, clinical, and commercial batches in a cGMP environment. Technical expertise in AKTA purification skids, TFF, and familiarity with batch records and technical documents is essential.

Essential Duties & Responsibilities:

• Execute and supervise downstream processes at various scales in a cGMP environment, including column packing, process troubleshooting, and data analysis.
• Provide technical direction for purification processes.
• Collect and evaluate operating data, and conduct online adjustments to products, instruments, or equipment.
• Prepare and review quality management documents (Deviation, Change Control, Investigation Reports, etc.).
• Ensure...