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.