AM/DM- Production -Downstream (biologics) (India)

AM/DM- Production -Downstream (biologics) (India)

01 Nov
|
Talental Consultings
|
India

01 Nov

Talental Consultings

India

Roles & Responsibilities:

- Lead downstream manufacturing operations for microbial fermentation-derived products.
- Handle end-to-end downstream processes including:
- Cell harvesting and broth clarification.
- Centrifugation and filtration.
- Cell disruption / homogenization.
- Inclusion body processing and solubilization, wherever applicable.
- Protein recovery, purification and concentration.
- Chromatography operations (Affinity, Ion Exchange, HIC, SEC).
- Ultrafiltration and Diafiltration (UF/DF).
- Final filtration and bulk formulation.

- Ensure effective execution of manufacturing batches as per BMRs, SOPs and cGMP requirements.
- Drive process optimization, yield improvement, cycle-time reduction and cost efficiency.
- Coordinate with Upstream Manufacturing, QA, QC, MSAT and Engineering teams.
- Handle technology transfer, scale-up, process validation and process characterization activities.




- Ensure compliance with GMP, biosafety, EHS and regulatory requirements.
- Lead troubleshooting, deviation investigations, CAPA and change control activities.
- Manage manpower, equipment utilization and manufacturing schedules.

Desired Candidate Profile

- B. Tech / M. Tech / M. Sc. in Biotechnology, Biochemistry, Microbiology or related discipline.
- Relevant experience in downstream processing of microbial fermentation-based products.
- Robust hands-on experience in protein purification and recovery.
- Exposure to large-scale manufacturing operations and chromatography systems.
- Experience in handling microbial-derived proteins, enzymes, recombinant proteins or biosimilars will be preferred.

📌 AM/DM- Production -Downstream (biologics) (India)
🏢 Talental Consultings
📍 India

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