Downstream Manufacturing Specialist

2 weeks ago


New York, New York, United States Joulé Full time
Job Title:

Downstream Manufacturing Scientist


Job Summary:

We are seeking a highly skilled Downstream Manufacturing Scientist to join our team at Joulé. As a key member of our biopharmaceutical manufacturing team, you will be responsible for executing the purification of mammalian cell-based cultures and producing recombinant proteins for a wide range of mammalian-based biosimilars.

The successful candidate will have technical expertise in AKTA purification skids or similar and Tangential Flow Filtration (TFF). You will be responsible for the purification of 50L to 1000L volumes of engineering, clinical, and commercial batches in a cGMP environment.

Responsibilities:
  • Execute purification of mammalian cell-based cultures and produce recombinant proteins for mammalian-based biosimilars
  • Purify 50L to 1000L volumes of engineering, clinical, and commercial batches in a cGMP environment
  • Have technical expertise in AKTA purification skids or similar and Tangential Flow Filtration (TFF)
  • Be knowledgeable about initiating batch records, protocols, investigations, and other technical documents
Requirements:
  • Bachelor's or Master's degree in chemical, biological, or biochemical sciences
  • 4-5 years of experience in the biopharmaceutical industry
  • Previous experience working in a GMP and an aseptic manufacturing environment
  • Experience working with AKTA Process skids or similar
  • Familiarity with single-use manufacturing consumables such as bags, tube sets, columns, and process manifolds
  • Possess knowledge to execute engineering and clinical batches; familiar with GMP documentation
  • Basic computer skills, including knowledge of Word, Excel, and spreadsheet
  • Knowledge of GMP batch manufacturing and packaging documentation; audit and review
  • Knowledgeable in cleaning verification/validation
About Joulé:

Joulé is a leading provider of biopharmaceutical manufacturing services. We are committed to delivering high-quality products and services to our clients.



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