System One Holdings, LLC
Downstream Manufacturing Scientist Job at System One Holdings, LLC in Piscataway
System One Holdings, LLC, Piscataway, NJ, United States
Job Title: Downstream Manufacturing Scientist
Location: Greater Piscataway, NJ area
Hours: 1st shift 8am-5pm
Type: Direct Hire
Responsibilities:
Requirements:
Location: Greater Piscataway, NJ area
Hours: 1st shift 8am-5pm
Type: Direct Hire
Responsibilities:
- As a Downstream Manufacturing Scientist you would be responsible for executing purification of mammalian cell-based cultures and producing recombinant proteins for a wide range of mammalian based biosimilars.
- As the Downstream Manufacturing Scientist, you will be responsible for the purification of 50L to 1000L volumes engineering, clinical and commercial batches in a cGMP environment.
- You would need to have technical expertise in AKTA purification skids or similar and Tangential Flow Filtration (TFF)
- You would need to 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 of 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 spread sheet
- Knowledge of GMP batch manufacturing and packaging documentation; audit and review.
- Knowledgeable in cleaning verification/validation