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Downstream Production Manager
3 months ago
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.
