Principal Associate/Scientist I Process Development Upstream

Location
San Diego, CA, United States
Posted
Nov 08, 2018
Ref
1-184
Hotbed
Biotech Beach
Required Education
Masters Degree/MBA
Position Type
Full time
Responsibilities:

The candidate will be in a process development and clinical manufacturing team. The candidate will focus on the development work of upstream cell culture and virus amplification/virus-like-particles transfection with disposable bioreactors, and support downstream purification with Chromatography method.

Develop and optimize the cell culture parameters (for various cell lines) and nutrient requirement in shaker flasks and disposable bioreactors (10L, 50L and 200L) for mammalian suspension cell growth for Virus and virus like particle production.

Develop and optimize the viral amplification/virus-like-particle transient transfection process to maximize the yield.

Develop and optimize the microfiltration process to concentrate the cells for viral amplification/virus-like-particle transient transfection.

Use DOE software to design the experiment, analyze the results for the virus/virus-like-particle yield improvement.

Write technical reports and transfer the method and work with clinical production team to support/generate the SOPs/batch record and produce the clinical trial materials.

Support investigational new drug (IND) chemistry-manufacturing-control (CMC) section writing.

Support downstream purification team for the development work (tangential flow filtration, anion exchange chromatography purification and sterile filtration) and clinical trial material production as needed.

Guide/train junior level associates

Technical Skills and Knowledge:

  • Cell culture experience is necessary.
  • Bioreactor experience is necessary
  • Design of Experiment (DoE) is necessary
  • Electroporation experience is preferred
  • Anion Exchange Purification experience is preferred
  • Diafiltration/Ultrafiltration experience is preferred
  • Good data analysis skills
  • cGMP experience is preferred
  • Molecular biology and virology knowledge is preferred
  • Good aseptic techniques
  • Good writing skills

Qualification Requirements:

  • Minimum of 2 years of experience in the mammalian cell culture and bioreactor experience
  • Degree in chemistry, biochemistry, pharmaceutical sciences, chemical engineering or a related field
  • MS degree with over 3 three years' industrial experiences or Ph.D. degree with 0-2 years' industrial experiences are required.
  • Excellent written and verbal communication skills required.
  • Record of successful publication is a plus

Travel:

Minimum travel