Downstream Production Manager in New Jersey

We are recruiting a Downstream Production Manager 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...