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Downstream Production Manager

2 months ago

Piscataway, United States Global Life Science Hub Full time
Job DescriptionJob Description

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.