Senior QC Scientist

3 weeks ago

Noida, Uttar Pradesh, India Tek Support Full time
Job Description

Role: Senior QC Scientist (CAR-T Manufacturing)

Location: Noida,IND (Remote)

Position Type: Full-time

Position Summary:

We are seeking an experienced Senior Quality Control Scientist with 10+ years of hands-on expertise in analytical and microbiological testing to support CAR-T manufacturing operations. The role involves ensuring product safety, potency, and compliance with cGMP and regulatory requirements through execution, oversight, and review of laboratory testing. This position is highly technical and requires deep knowledge of analytical methods such as flow cytometry, ELISA, and qPCR, as well as microbiological and environmental monitoring techniques.

Key Responsibilities:

- Perform and oversee advanced bioanalytical testing, including qPCR, flow cytometry, ELISA, cell count, and cell viability assays.
- Manage and execute microbiological and environmental monitoring (EM) testing, including sterility, endotoxin, mycoplasma, and gram staining.
- Review, analyze, and approve QC data to ensure accuracy, compliance, and timely release of results.
- Support and guide junior chemists and scientists in laboratory best practices, method execution, and compliance requirements.
- Lead and contribute to OOS/OOE investigations, deviations, and CAPA development, ensuring thorough root cause analysis and effective corrective actions.
- Collaborate with cross-functional teams (Manufacturing, QA, Regulatory) to support clinical and commercial CAR-T manufacturing.
- Ensure adherence to cGMP, data integrity, and quality standards across all QC operations.
- Support validation, qualification, and lifecycle management of analytical methods and QC instrumentation.
- Author, review, and revise SOPs, test methods, protocols, and technical reports.
- Drive continuous improvement initiatives within the QC department to enhance efficiency, reliability, and compliance.

Qualifications:

- Bachelors or Masters degree in Chemistry, Biochemistry, Microbiology, or related field.
- Minimum 10 years of progressive experience in Quality Control within pharmaceutical, biotechnology, or cell therapy environments.
- Proven expertise in bioanalytical methods (qPCR, flow cytometry, ELISA) and micro/EM testing.
- Strong understanding of cGMP, regulatory expectations (FDA/EMA), and quality systems
- Demonstrated ability to lead investigations, train staff, and provide technical oversight.
- Excellent documentation, organizational, and communication skills.

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