MSAT Downstream

Position: Asst. Manager- Downstream

Location: Bengaluru, India.

Job Responsibilities:

Essential Qualification/ Experience:

M.Tech. in Biotechnology/ Bioprocess Technology/ Bio-Separation with experience of 5-8 years in Biologics manufacturing/ MSAT/ R&D Laboratory.

Technical Skills:

Good Understanding of Bio-separation processes, downstream process calculations. Downstream process unit operations, design, development, process characterization and validation. Data mining and evaluation.

Job Responsibilities:

1. 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.
2. 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.
3. Planning and execution of small-scale experiments related to process improvement, process investigation, scale-up, process fine-tuning, evaluation alternates/ new technology, life cycle management and supporting scale-up, tech transfer, debottlenecking and productivity and throughput increase, COGS reduction initiatives wherever applicable.
4. Authoring and reviewing of technical documents, SOPs, protocols in accordance with GDP/cGMP and best compliance practices.
5. Preparation and Review of Impact assessments for RMs, Consumables, evaluation of alternative vendors for COGs improvement and process robustness.
6. Investigation for process related QMS elements, tracking and closure of QMS elements.
7. Conduct risk assessments and mitigation strategies to ensure process safety and product quality.
8. Effectively work and communicate with team, CFTs and partners for planning and execution of downstream process improvement activities and formulation/ review/ revision of procedural controls and procedures in the processes and its implementation in the manufacturing process.
9. Follow and adhere to rules, regulations and procedures, data integrity, good documentation practices and compliance in performing the assigned activities.
10. Experience with data analysis tools and software such as JMP, Minitab, QMS software