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Senior Research Associate- Bio Analytical Assay- Biosimilar

Senior Research Associate- Bio Analytical Assay- Biosimilar

Enzene

5 - 8 years

5 - 10 Lacs

pune

Posted:3 hours ago| Platform:

Apply

Skills Required

bioassay cell based assay elisa biosimilars method validation method development moa hplc

Work Mode

Work from Office

Job Type

Full Time

Job Description

Role & responsibilities

Assay Development & Execution:

Perform
method development, method qualification, and sample analysis
for SPR, BLI, cell-based assays, and ELISA.
Independently design, execute, and troubleshoot assay protocols.
Ensure timely completion of all analytical activities with high scientific quality.

Documentation & Reporting:

Prepare and review technical documents including
dMOA, MQP, MQR, MTP
, and other assay-related reports.
Maintain accurate, complete, and compliant records following
Good Documentation Practices (GDP)
.
Contribute to data interpretation, documentation, and presentation of results.

Equipment Management:

Perform
routine preventive maintenance (PM)
and
calibration
of laboratory equipment.
Ensure instruments are in optimal condition and maintain proper usage logs.
Coordinate with service engineers for repairs and troubleshooting when needed.

Compliance & Quality:

Adhere to all
lab safety guidelines
, SOPs, GDP, and quality systems.

Support audit readiness and contribute to continuous process improvements

Qualifications & Skills

Masters degree in Biotechnology, Biochemistry, or related life science discipline.
5-8 years
of hands-on experience in
SPR, BLI, ELISA, and cell-based assays
.
Strong understanding of assay development, qualification, and validation principles.
Proficiency in scientific writing and technical document preparation.
Good analytical skills, attention to detail, and ability to work independently as well as in a team.

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