*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 global 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.
division
operations
business unit
innovative medicines
location
mexico
site
insurgentes
company / legal entity
mx06 (fcrs = mx006) novartis farmacéutica s.a. de c.v.
functional area
technical operations
job type
full time
employment type
regular
shift work
no
*accessibility and accommodation*:
novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.