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Downstream Manufacturing Specialist

2 months ago

Piscataway, New Jersey, 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 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.

Responsibilities:
  • Execute purification of 50L to 1000L volumes of engineering, clinical, and commercial batches in a cGMP environment.
  • Develop and implement efficient purification processes using AKTA purification skids or similar.
  • Collaborate with cross-functional teams to ensure seamless execution of manufacturing processes.
  • Develop and maintain technical documents, including batch records, protocols, and investigations.
  • Ensure compliance with GMP regulations and industry standards.
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 aseptic manufacturing environment.
  • Technical expertise in AKTA purification skids or similar.
  • Familiarity with single-use manufacturing consumables.
  • Strong knowledge of GMP documentation and batch manufacturing processes.