Sr. Associate/Principal Associate Product Development

Location
San Diego, CA, United States
Posted
Nov 27, 2018
Ref
21-186
Hotbed
Biotech Beach
Required Education
High School or equivalent
Position Type
Full time
Summary Description of Role:

The position will be a supporting member of the Product Development team and will report to the Sr. Director, Product Development. This position will be focused on the support of analytical assay work to screen vaccine stabilization formulation and develop process to manufacture vaccine in liquid or powder dosage form.

Responsibilities:

The Product Development team member will be responsible for the ongoing cell culture work, CFU and TCID50 analysis of different formulations. Candidate will be proficient in concentration calculations and buffer preparations. Candidate should have a strong mathematical skills and chemistry background is a plus. Candidate will be responsible for dose preparation for animal studies.

Technical Skills and Knowledge:

  • Provide Liquid and Powder formulation analytical support
  • Ability to handle Virus like particle, Adenovirus and Bacterial formulation
  • Cell Culture and cell based assay experience
  • Ability to perform TCID50 Assay/ELISA/PCR
  • Ability to perform Colony Forming Unit (CFU) assay
  • Ability to perform DLS, Moisture content, Disintegration, UV Vis, Intrinsic Fluorescence measurement
  • Pharmacy manual preparation for clinical studies
  • Ability to organize development stability study
  • Perform assigned quality control testing based on SOP
  • Maintenance of mammalian cell cultures
  • Participates in qualification and validation of QC test methods.
  • Writes and revises standard operating procedures and other related GLP/GMP documentation.
  • Reviews data obtained for compliance to specifications and reports abnormalities.
  • Provides back-up assistance for other QC program and raw materials
  • Buffer preparation

Qualification Requirements:

  • 2-6 years of experience in the biopharmaceutical industry and knowledge of dry oral solid dosage form and liquid dosage forms.
  • A minimum of a high school degree or BS degree in chemistry, biochemistry, molecular biology or a related field.
  • Excellent written and verbal communication skills required.
  • Strong assessment and troubleshooting skills.


Travel:

  • None