Quality Control Associate - Bioassay ( Supervisor )

Biopharma Careers; Hyderabad; On-site; INR 1,800,000 - 2,800,000; Full time

Job summary

Dr. Reddy’s is seeking a qualified Biologics QA professional to test samples and release results within stringent TAT, adhering to GMP and GDP guidelines. The role involves calibrating and maintaining analytical equipment, validating procedures, and ensuring accuracy of reports in a cGMP environment.

The candidate will work on cell-based bioassays, ELISA, and PCR analyses, with experience in BA labs and protein chemistry beneficial. Collaboration and documentation are essential.

Qualifications

• An M.Sc., M.Tech. or B.Tech. in Microbiology, Biochemistry, or Biotechnology.
• 6–10 years of relevant work experience in biologics/biosimilar labs.
• Hands-on proficiency with BA assays, ELISA, PCR and related analytics.

Responsibilities

• Bioassay testing for assigned samples and releasing data within defined timelines.
• Prepare reagents and buffers per testing plan and ensure equipment availability.
• Document activities per GDP and perform self-checks for accuracy.
• Inform supervisor of risks with data to support investigations and audits.
• Maintain lab cleanliness, proper storage, labeling, calibration, and instrument maintenance.

Skills

Bioassay testing

Cell culture exposure

ELISA & PCR

cGMP/GDP knowledge

Data integrity & GDP

Root cause analysis

Education

M.Sc./M.Tech./B.Tech. in Microbiology/Biochemistry/Biotechnology

Tools

SPR

FACS

Electrophoresis

Job description

Job Summary

We are seeking an individual to test samples and release results within Turnaround Time (TAT) for commercial and stability batches, adhering to GMP (Good Manufacturing Practices). This role involves calibrating and maintaining assigned equipment within departmental and organizational guidelines, processes, and procedures. The primary objective is to ensure accuracy in results provided within timelines.

Roles & Responsibilities

• Your responsibilities encompass Bioassay testing for assigned samples and releasing data within defined timelines, ensuring absence of executional errors against established procedures. You will be responsible for preparing required reagents and buffers in alignment with the testing plan and ensuring the availability of equipment for analysis.
• Your role involves documenting activities contemporaneously, adhering to Good Documentation Practices and compliance expectations, and conducting self-checks post-analysis to ensure accuracy.
• You will promptly inform the supervisor about risk actions, providing necessary data and analysis to support the investigation process. You will adhere to QMS (Quality Management systems) and closure timelines, actively participate in laboratory investigations and discrepancy closures, fulfilling defined roles in audits.
• Your responsibilities also include ensuring lab cleanliness, proper sample storage, chemical labeling, removal of expired material, usage of calibrated equipment, equipment calibration, maintenance, and qualification.
• You will address instrument-related issues and conduct root cause analyses (RCAs) for unknown problems, and play a crucial role in training new team members on analytical techniques.

Educational Qualification

An M.Sc., M.Tech. or B.Tech. in Microbiology, Biochemistry, or Biotechnology

Minimum Work Experience

6 - 10 years

Technical Skills

• Basic understanding of the Biologics/Biosimilar industry, including processes, regulations, and trends.
• Hands-on experience in cell based bioassays, SPR technique, FACS techniques.
• Basic knowledge and hands-on exposure to cell culture techniques, specifically for working in Bioassay (BA) Labs.
• Hands-on experience in Biochemical analysis techniques, specifically Electrophoresis, Enzyme-Linked Immunosorbent Assay (ELISA), and Polymerase Chain Reaction (PCR), with a focus on Analytics.
• Working experience in a cGMP (Current Good Manufacturing Practice) environment, with a special emphasis on Good Documentation Practices (GDP).
• Basic knowledge in protein chemistry, including an understanding of protein structure, function, and relevant analytical techniques.
• Basic understanding about bioassay method validations.

Behavioural Skills

• Prioritizes effective communication and demonstrates a performance-oriented mind-set.
• Effective verbal and written communication skills.
• Performance-oriented approach, consistently striving for high standards.
• Demonstrates flexibility in working shifts and a clear understanding of team dynamics.

About the Department

BiologicsCurrently operates in the Global Biosimilars business - a segment that is poised for attractive and sustained growth over the next 10–15-year time horizon...

Benefits Offered

At Dr. Reddy’s, we actively help to catalyze your career growth and professional development through personalized learning programs. The benefits you will enjoy at Dr. Reddy’s are on par with the best industry standards...

Our Work Culture

Ask any employee at Dr. Reddy’s why they come to work every day and they’ll say, because Good Health Can’t Wait. This is our credo as well as the guiding principle behind all our actions...