Perform in-process and release testing of CAR-T products.
- Conduct assays including flow cytometry qPCR, ELISA, and microbiological
assays.
- Develop, validate, and transfer analytical methods for CAR-T product testing.
- Troubleshoot analytical methods and provide technical support during investigations. ...
- Analyze and interpret QC data, prepare statistical reports, and present results to teams.
- Author, review, and approve QC protocols, procedures, and documentation.
- Ensure regulatory compliance with GMP QC protocols across PoC centers.
- Manage lab supplies, reagents, and inventories effectively.
- Lead investigations of OOS/OOT results, generate deviation reports, and execute CAPA. Requirements:
- Bachelor’s/Master’s degree in Biotechnology, Life Sciences, or related field.
- Minimum 5 years of QC experience in biologics or cell therapy manufacturing.- Strong understanding of GMP and QC documentation practices.
- Willingness to travel extensively across India for the first two years.
- Excellent analytical, organizational, and communication skills.
experience
10show more Perform in-process and release testing of CAR-T products.
- Conduct assays including flow cytometry qPCR, ELISA, and microbiological
assays.
- Develop, validate, and transfer analytical methods for CAR-T product testing.
- Troubleshoot analytical methods and provide technical support during investigations.
- Analyze and interpret QC data, prepare statistical reports, and present results to teams.
- Author, review, and approve QC protocols, procedures, and documentation.
- Ensure regulatory compliance with GMP QC protocols across PoC centers.
- Manage lab supplies, reagents, and inventories effectively.
- Lead investigations of OOS/OOT results, generate deviation reports, and execute CAPA. Requirements:
- Bachelor’s/Master’s degree in Biotechnology, Life Sciences, or related field.
- Minimum 5 years of QC experience in biologics or cell therapy manufacturing.- Strong understanding of GMP and QC documentation practices.
- Willingness to travel extensively across India for the first two years.
- Excellent analytical, organizational, and communication skills.
experience
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