The Production Associate – Cell Culture will be responsible for executing upstream processes involved in mammalian cell culture for vaccine and biopharmaceutical manufacturing. The role includes media preparation, cell expansion, bioreactor operations, and ensuring aseptic handling in compliance with GMP guidelines. The position supports daily production activities, documentation, and continuous improvement to achieve high-quality and consistent production output.

KEY RESPONSIBILITIES

1.      Perform aseptic cell culture operations, including thawing, seeding, passaging, and harvesting.

2.      Prepare culture media, buffers, and reagents as per approved procedures.

3.      Operate, monitor, and maintain bioreactors and associated upstream equipment.

4.      Maintain batch documentation, logbooks, and production records as per GMP.

5.      Follow EHS, aseptic, and contamination-control practices in the production area.

6.      Support process optimization, troubleshooting, and continuous improvement initiatives.

DUTIES AND RESPONSIBILITIES (briefly write your responsibility of works)

Cell Culture Operations

a. Perform routine mammalian cell culture activities using aseptic techniques.
b. Monitor cell growth parameters, viability, and morphology.
c. Execute cell expansion processes from seed culture to production scale.

Media & Buffer Preparation

a. Prepare and sterilize media, buffers, and supplements required for cell culture.
b. Perform in-process quality checks such as pH, osmolality, and sterility.

Bioreactor & Equipment Handling

a. Operate single-use and stainless-steel bioreactors according to SOPs.
b. Calibrate, sanitize, and maintain critical upstream equipment including incubators, centrifuges, and filtration units.

GMP Documentation & Compliance

a. Accurately document all production activities in BMRs, logbooks, and forms.
b. Ensure compliance with GMP, GDP, EHS, and regulatory guidelines during all operations.

Cross-Functional Support & Continuous Improvement

a. Collaborate with QA, QC, Engineering, and R&D teams for smooth production operations.
b. Participate in investigations, CAPAs, change controls, and process improvements.

GENERAL NOTES:

·        Maintain cleanliness and controlled environmental conditions inside the production facility.

·        Strict adherence to gowning procedures, contamination-control practices, and safety guidelines.

·        Demonstrate teamwork, discipline, and responsibility to support uninterrupted production.

·        Be willing to work in shifts, weekends, and as per production requirements.