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