Job Description

Experience- 1 to 3 Years (Antisera Industry)

Job Responsibilities

Sample Analysis:

Perform testing on raw materials, intermediates, and finished antisera products using analytical techniques like

HPLC

,

UV-Vis spectrophotometry

, and electrophoresis.

Potency & Biological Testing:

Conduct specific assays to verify the efficacy of the antisera against targeted toxins or viruses, including

bacterial endotoxin tests (BET)

and sterility testing.

Environmental Monitoring:

Carry out microbial swabbing and air sampling in sterile manufacturing areas to prevent contamination during the filling of serum vials.

Instrument Calibration:

Execute daily and monthly calibration of lab equipment (e.g., pH meters, analytical balances, HPLC) to maintain data accuracy.

Stability Studies:

Monitor the shelf-life of antisera batches by performing periodic testing under varied storage conditions.

Documentation & Compliance:

Maintain real-time records following

Good Laboratory Practices (GLP)

and

ALCOA++

data integrity principles.

Investigation of Deviations:

Report and investigate

Out of Specification (OOS)

or Out of Trend (OOT) results to identify root causes.

SOP Maintenance:

Prepare and revise

Standard Operating Procedures (SOPs)

and testing specifications for serum production.

Qualifications & Skills

Education:

A Bachelor's or Master's degree in

Biotechnology

,

Microbiology

,

Biochemistry

.

Technical Expertise:

Hands-on experience with biological assays, aseptic techniques, and advanced analytical instruments like

HPLC

and

GC

.

Regulatory Knowledge:

Deep understanding of

cGMP

,

GLP

, and international standards like

WHO

or

ICH

guidelines for immunobiological.

Analytical Skills:

Proficiency in statistical data analysis and the ability to interpret complex biological test results.

Certifications:

Additional certifications in

Quality Management Systems (QMS)

or specialized training in biological safety are often preferred.
Job Types: Full-time, Permanent

Pay: ?20,000.00 - ?25,000.00 per month

Benefits:

Food provided Health insurance Paid sick time Provident Fund
Work Location: In person