**Summary**:The MS&T; Engineer(Manufacturing Science and Technology), is responsible for conducting process maintenance and data analysis activities associated with the drug substance (expansion, upstream and downstream) and/or drug product manufacturing processes used to manufacture gene therapy products.These activities are associated only with responsibilities which can be executed from a fully remote location.
**About the Role**:**Responsibilities**:- Performs all maintenance and regulatory oversight activities associated with the Master and Working Cell Banks, Bulk Plasmids, and Plasmid Cell Banks- Serving a primary interface with 3rd party contract manufacturers for cell banks and plasmids- Tracking inventory and managing orders and manufacturing oversight of each batch- Maintaining specifications for cell banks and plasmids- Ensuring compliance with all regulatory filing requirements associated with cell banks and plasmids- Participation in audit defense and risk management activities for cell banks and plasmids- Ensuring appropriate stability program execution and annual filings of re-test dates as required- Partnering with the Upstream MSAT Manager and Strategic Product lead on long term strategies for management of cell bank and plasmids- Ensuring deviation oversight and providing guidance to CMOs during manufacture- Maintaining appropriate documentation for the management of banks such as high level plans, protocols, specs,



and certificates of analysis- Perform marketing and post-marketing commitments related to banks and plasmids- Participate in any technical transfer activities required to produce or test banks and plasmids- Execute on assessments of Supplier Change Notifications and implement change requests as needed- Perform trending and data analysis of parameters and attributes associated with the production of these materials as well as the potential output parameters in the process- May support the reporting outputs for the Continued Process Verification (CPV) program in collaboration with other MSAT functions- Execute periodic review of documentation and gap assessments of global SOPs- Assist with the update and routing of lifecycle documentation as needed such as Leachable extractable assessment and coordination of studies (as needed), control strategy and process description documents, etc.- Looks for opportunities to implement operational excellence and continuous improvement- Partners with Quality to ensure a compliant manufacturing environment- Participates in GTx pipeline technical transfer activities where new banks or plasmids are needed to transition to commercial- Completes requisite training, as well as applicable policies and procedures,



related to the job function- May work on special projects related to development and improvement of business and/or manufacturing processes- Other related duties as assigned**Requirements**:- Bachelor's degree in biochemistry, chemical engineering, bioengineering, or related technical field at least 4 years of experience in biopharmaceutical based GMP manufacturing operations including direct experience in cell culture, cell banking, and/or management of 3rd party CMOs in biopharmaceutical or cell and gene therapy operations.
- Bachelor's degree in biochemistry, chemical engineering, bioengineering, or related technical field at least 3 years of direct Novartis GTx experience.
- Master of Science degree in biochemistry, chemical engineering, bioengineering, or related technical field and at least 2 years of experience in support of biopharmaceutical manufacturing, or related engineering field.
- Familiar with integral regulations on cGMP manufacturing of drug substance, drug products devices, validation/qualification requirements.
- Strong technical writing ability in English.
- Proven ability to effectively participate on teams.
- Excellent oral and written communication skills.
- Up to 15% travel.DivisionOperationsBusiness UnitInnovative MedicinesLocationMexicoSiteINSURGENTESCompany / Legal EntityMX06 (FCRS = MX006) Novartis Farmacéutica S.A. de C.V.Functional AreaTechnical OperationsJob TypeFull timeEmployment TypeRegularShift WorkNo**Accessibility and accommodation**:Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

📌 Ms&T Engineer (Xico)
🏢 Novartis
📍 Xico