Senior Executive - MSAT

Role & Responsibilities

• Represents Manufacturing Science and Technology (MSAT) on project teams as technical subject matter expert SME and interface relevant stakeholders.
• Authors/reviews change controls, investigations and CAPAs, including managing the implementation of the change as the assigned change agent.
• Author/review process validation protocols, tech-transfer plan, protocols and reports, MFRs and NPIFs.
• Strategize scale-up and scale-down, review process characterization studies and assess to align with manufacturing process requirements.
• Thorough knowledge of upstream and downstream techniques like chromatography, filtration, UF/DF, Bioreactor operations, cell culture techniques etc at different scales.
• Design and draft process validation protocols, execution monitoring and reports.
• Monitors and reports on process performance manufacturing data analysis and delivery of data in the form of live presentations.
• Perform facility fit assessment, process risk evaluation, and complete process transfer documentation.
• Responsible to work with cross-functional teams tasked with technology transfers (process design and up-scaling) and timely process implementation at the manufacturing scale.
• Act as the interface between the process donor (customer, process development, R&D) and manufacturing.
• Act as a second line support of the manufacturing team for all process related issues either on call or by overseeing process steps during manufacturing in the facility.
• Direct communication with stakeholders including customers during campaign preparation, execution, and closure including regular reporting of batch status and process performance.
• Responsible for the resolution of process issues that may arise during manufacturing, considering all regulatory requirements.
• Provide process know-how as well as scientific and operational excellence expertise in connection with the biologics production.
• Secure technology transfer success by applying standardized processes and tools to manage the transfer of information, process-related risks, and change control.
• Attending on job training and updating individual training record.
• Live the Enzene values of Innovation, Respect, Candor, Excellence, Entrepreneurship and Integrity.

Skills Required
Data Analysis, Chromatography, Filtration