QC Associate -Cell and Gene Therapy Products_Hyderabad

4 - 9 years

6 - 13 Lacs

Posted:16 hours ago| Platform: Naukri logo

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Job Type

Full Time

Job Description

Role & responsibilities

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.

Preferred candidate profile

- Bachelors/Masters degree in Biotechnology, Life Sciences, or related field.

- Minimum 5 years of QC experience in biologics or cell therapy manufacturing.

- Hands-on experience with PCR is highly desirable.

- 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.

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