Lead Bioanalytical Scientist

1 day ago


Noida, Uttar Pradesh, India beBeeScientist Full time ₹ 1,50,00,000 - ₹ 2,50,00,000
Senior Scientist - Quality Assurance

The role of Senior Scientist is critical to the success of our CAR-T manufacturing operations. This position will lead and contribute to investigations, deviations, and CAPA development, ensuring thorough root cause analysis and effective corrective actions.



Responsibilities:

• Perform 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 junior scientists in laboratory best practices, method execution, and compliance requirements.

• 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.

• Validate, qualify, and manage 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:

• Bachelor's or Master's degree in Chemistry, Biochemistry, Microbiology, or related field.

• Minimum 10 years' 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, and quality systems

• Ability to lead investigations, train staff, and provide technical oversight.

• Excellent documentation, organizational, and communication skills.
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