Senior Research Associate, Analytical Development
The Senior Research Associate, Analytical Development will be a supporting member of the AD and QC team. The candidate will report to the Bioassay Group in AD. This position will be focused on the technical support needed for assay development, internal studies and, GMP/QC test for release and stability programs of DS and DP.
The Senior Research Associate will be working in between the AD/QC environment. S/he will be responsible for the ongoing cell culture, TCID50, PCR/qPCR analysis and other analytical assays of DS and DP including identity (Western Blot) and purity (SDS-page). Candidate will be proficient in concentration calculations and buffer preparations, and perform assays with an accurate and reproducible technique. The candidate will efficiently execute GMP assay and deliver data in a timely manner with high accuracy. Collaborate and support group members.
Technical Skills and Knowledge:
- Ability to handle Adenovirus
- Cell Culture and cell based assay experience
- Ability to perform TCID50 Assay/qPCR/ELISA
- Ability to perform SDS page, Western Blot, GXII
- Ability to organize, plan and execute efficiently the daily work
- Maintain accurate and detailed notes
- Maintenance of mammalian cell cultures
- Participates in Bioassay development
- Participates in qualification and validation of QC test methods
- Perform assigned quality control testing based on SOP in GMP environment.
- 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
- Support daily lab activity including purchasing and lab organization
- Familiar with Word, Excel and PowerPoint
- 5-8 years of experience in the biopharmaceutical industry with hands on tissue culture, qPCR, SDS page and Western Blot.
- A minimum of BS degree in biology or biochemistry.
- Excellent written and verbal communication skills required.
- Strong assessment and troubleshooting skills.