Principal Associate/Scientist I Process Development Upstream

Location
San Diego, CA, United States
Posted
Sep 12, 2018
Ref
1-148
Hotbed
Biotech Beach
Required Education
Associate Degree
Position Type
Full time
Summary Description of Role:

This is an incredible opportunity to join a small but growing clinical stage pharmaceutical company with a bright future. PaxVax, Inc. is seeking a Principal associate or Scientist I of process development to join the Process Development and Clinical Production department. The successful candidate will be expected to work as part of a team that is focused on the process development for vaccine development from preclinical through Phase III, and commercialization. The main responsibilities will include the design, execution, and documentation of experiments to develop/optimize upstream (bioreactor, transfection, microfiltration, filtration) for clinical supply production and to scale up these processes to enable transfer of robust processes to the commercial space. The successful candidate will be able to work in a fast-paced team environment and be able to learn new skills quickly. The candidate at PaxVax will be a key member of the Process Development team and will report to the Sr. Scientist/Manger, process development.

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