Downstream Production Manager

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 timely execution of engineering and clinical batches.
• Establish equipment specifications and improve manufacturing techniques.
• Collaborate with other teams and outside vendors to resolve technical issues and maintain production equipment.
• Lead GMP compliance and follow environmental health and safety policies.
• Coordinate investigations and corrections for issues during batch execution.
• Perform other assigned functions and comply with all company policies and standards.

Requirements:

Education:

• Bachelor’s or Master’s degree in chemical, biological, or biochemical sciences.
• 7-10 years of related experience in the biopharmaceutical industry.
• Experience in GMP and aseptic manufacturing environments.
• Familiarity with AKTA Process skids and single-use manufacturing consumables.

Special Skills:

• Strong interpersonal skills and ability to work independently.
• Excellent communication, documentation, and organizational skills.
• Proficiency in Word, Excel, and spreadsheet applications.
• Knowledge of GMP batch manufacturing, packaging documentation, and cleaning verification/validation.

Work Environment & Physical Demands:

• Ability to work flexible hours as needed.
• Capacity to work under pressure and meet deadlines.
• Some travel may be required.