Downstream Manufacturing Supervisor in New Jersey

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...