Analyst - Quality Control (Microbiology)

About Immuneel

Immuneel Therapeutics Private Limited is a pioneering start-up company leading the charge in cell therapy and personalized immunotherapy for patients in India. For more details, please refer

We Pursue, with Purpose, to serve our Patients (3 Ps) by Connecting within, Collaborating globally and Creating (3 Cs) solutions. Our flexible, diverse, and vibrant team is bringing together best practices and innovations in the field of cell and gene therapy.

Working at Immuneel promises the excitement of an agile start-up on a critical mission. Proudly Indian in solutioning, yet global in outlook, we are keen to collaborate. We value diversity including in experience and perspectives. We value work-life balance and believe that having fun on the job is integral to achieving the right results. We pride ourselves on providing an open environment and our mission resonates with humanity everywhere. At Work, we are :

Passionate in driving patient outcomes : We are passionately committed to doing the RIGHT thing to achieve the best outcomes for our patients through innovation, agility and performance orientation. We put the impact on the patient above all else.

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Inclusive and flexible : We are full of life and embrace all opportunities to collaborate and work together. We are excited about the collective knowledge and expertise that we share. “Being and thinking different” is valued.

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1. Role Title :

Analyst - Quality Control (Microbiology)

2. Department / Function :

Quality Control

3. Reporting Structure :

Reports to : Specialist - Quality Control

Direct Reports : NA

4. Role Summary :

The quality control team focuses on stringent quality check of products, coming out of manufacturing units for final release and subsequent use in the patients. The Analyst-Microbiology focusses on qualification, validation and batch release of Microbiological assays for CAR T products. The candidate will also be performing stability studies and Raw material / Packing material / Consumables, in addition to batch release tests. The Microbiology analyst is responsible for Environmental monitoring in aseptic areas and QC area.

5. Key Responsibilities :

Environmental monitoring in clean rooms and contamination control strategy for manufacturing facility, QC labs and other clean rooms and controlled environments.

Perform Sterility, BET (Bacterial Endotoxin test), and Mycoplasma test for in-process samples and finished product.

Follow GXP, adhere to quality SOPs, and maintain logs, inventories, documentation, filing, etc.

Receipt of media plates and verification of COA for received media. Media handling, growth promotion test, and maintenance of records.

Upkeep of reconciliation records of microbiological medias.

Release RM, PM, and consumables as and when required.

To prepare EM trends for Aseptic areas and QC EM data.

To involve in QMS activities as and when required.

Operation and maintenance of lab equipment / instruments.

Responsible for maintaining laboratory logbooks and records according to GXP.

Scientifically sound / technical writing skill and having the knowledge of different regulatory guidelines.

To receive an issuance of samples for QC testing and to involve in sample management activities, requesting ATRs, and maintaining sample log and batch documents.

Able to work for extended hours / on weekends (if required).

6. Primary Objectives :

To perform environmental monitoring in clean rooms and controlled environments and to perform microbiological tests and report the results.

To perform documentation as per (GDP) Good Documentation Practices.

To escalate any discrepancy identified in QC labs to the reporting manager immediately.

7. Competencies Required :

Technical Competencies :

To have a sound knowledge of Microbiology and aseptic practices.

Hands-on experience in Microbiological assays is a plus

Soft Skills :

Team player and Adaptable

Good listener and Quick learner

Analytical ability

Maintain data integrity and commitment to quality

Confident and Self-motivated

Enthusiastic, Persistent, and Hard-Working

8. Qualifications :

M.Sc. Microbiology / Life sciences (with 2-4 years of experience).

9. Working Conditions :

Role Type : Full Time and Onsite

Work Hours : 9 : 00 AM to 6 : 00 PM for the General Shift and 2 : 00 PM to 11 : 00 PM for the Post-Noon Shift (on a rotational basis). There will be two days off each week, which may not necessarily fall on a Saturday or Sunday.

Travel Requirements : No

Base Location : Immuneel Therapeutics Private Limited, 8th Floor, Mazumdar Shaw Medical Center, Narayana Health City, Bommasandra Industrial Area, Bangalore – 560099