Senior Executive / Assistant Manager

Key Responsibilities:

- An executive with extensive expertise in Biologics Manufacturing: Product Technical Life Cycle Management.

- Lead MSAT cell culture upstream projects and technical investigator.

- Planning and designing using DOE approach for process development and characterization of upstream operations.

- Working as team with other cross functional teams and contributing the domain expertise for advancing the pipeline molecules as required.

- Identify opportunities for improving the product quality and quantity as per current and future market demand.

- Hold time study of all process intermediate, reagent, media & Feed.

- Perform all functions associated with process transfer and scale up to manufacturing e.g. develop process understanding, perform gap analysis / FMEA / RCA, generate process models, author / review process descriptions and batch Records, support equipment commissioning, process training, and validation activities.

- Perform all functions associated with process monitoring, trending of in process and lot release parameter and quality data by using various software tools e.g. manufacturing data summary and analysis, data presentation; author campaign summary reports, assess deviations and process changes.

- Continuous monitoring of manufacturing batches of assigned projects.

- Review of protocol, study report, SOP and review of lab documents.

- Play a member role in resolving technical issues for all functions to improve compliance throughout the site. Serve as investigation team member for process-impacting deviations and investigations. Provide technical guidance on change controls and how they might impact the processes and product specifications.

- Statistical data analysis & Develop the Statistical model for the batch monitoring.