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.
