06 Sep
|
BIOCON BIOLOGICS
|
Bengaluru
06 Sep
BIOCON BIOLOGICS
Bengaluru
Job Description
Position: Asst. Manager- Downstream
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nLocation: Bengaluru, India.
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nJob Responsibilities:
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nEssential Qualification/ Experience:
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nM.Tech. in Biotechnology/ Bioprocess Technology/ Bio-Separation with experience of 5-8 years in Biologics manufacturing/ MSAT/ R&D; Laboratory.
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nTechnical Skills:
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nGood Understanding of Bio-separation processes, downstream process calculations. Downstream process unit operations, design, development, process characterization and validation. Data mining and evaluation.
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nJob Responsibilities:
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- Monitoring of Manufacturing process- Downstream part, Performing Continued process verification-data collection and review to ensure that the process is under validated state of controls and it delivers consistent product quality and yield consistently. Provide technical support during manufacturing campaigns, including troubleshooting, deviation investigations, and CAPAs.n
- Technology Transfer, scale-up and Validation: Facilitate the transfer of downstream processes to manufacturing,
including knowledge sharing and documentation. Develop and execute scale-up and validation protocols, ensuring processes meet regulatory requirements and specifications.n
- Planning and execution of small-scale experiments related to process improvement, process investigation, scale-up, process fine-tuning, evaluation alternates/ current technology, life cycle management and supporting scale-up, tech transfer, debottlenecking and productivity and throughput increase, COGS reduction initiatives wherever applicable.n
- Authoring and reviewing of technical documents, SOPs, protocols in accordance with GDP/cGMP and best compliance practices.n
- Preparation and Review of Impact assessments for RMs, Consumables, evaluation of alternative vendors for COGs improvement and process robustness.n
- Investigation for process related QMS elements, tracking and closure of QMS elements.n
- Conduct risk assessments and mitiga
📌 MSAT Downstream (Bengaluru)
🏢 BIOCON BIOLOGICS
📍 Bengaluru