Senior/Principal Associate, Product Development
The Senior Research Associate/Principal Research Associate will be a supporting member of the Product Development team and will report to the Director, Product Development. This position will be focused on the support of analytical assay work to screen vaccine stabilization formulation.
The Senior/Principal Research Associate, Product Development will be responsible for the ongoing cell culture, CFU and TCID50 analysis of experimental oral dose 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, which may include, but is not limited to cell based titer assay, moisture analysis, and disintegration.
- 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
- 4-6 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.