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Job Details
Novartis
Senior Manager Science & Technology (QC Bioanalytics)
Job Description
1 purpose! Novartis expands its early development and innovative CAR-T cell therapy manufacturing capabilities in its newly launched Center of Excellence, located in the East Hanover, NJ campus. Our therapies are being developed as transformative treatments with life-saving potential for various B cell malignancies and other oncological diseases. We look to be bold with purpose, as we reimagine medicine and lead the way in advancing scientific breakthroughs for patients.
The Senior Manager, Science & Technology (Bioanalytics) will coordinate and lead all activities to ensure the timely testing/release of all samples, set up laboratory planning to improve efficiency/throughput, lead the execution of validation and other major projects to assure GMP beyond compliance related to development/clinical operations at our Cell and Gene Therapy GMP facility! They will lead a group of lab associates and provide employees with training and resources to meet or exceed requirements. As the subject matter expert on specific areas and techniques, they will deliver quality products and services on time to all customers (internal and external); all while supervising processes and products to find opportunities for continuous improvements.
**Onsite 100% is required for this position. The schedule for this role is Wednesday - Saturday 4/10 hour days **
Your responsibilities will include, but are not limited to:
• Supervise, lead and perform scheduling of bioanalytical testing such as Flow, cell count, cell viability, Potency and qPCR following appropriate protocols, test methods, and compendia (United States Pharmacopoeia (USP), American Chemical Society (ACS)). Ensure all samples and reagents have been prepared, tested or inspected according to specifications and current testing. Assure qualification status of critical reagents.
• Primary point of contact for troubleshooting / Communication to Management during shifts. Organizes plans and provides support to the team members in any analytical/technical questions and problems, in order to ensure efficiency and accountability of the group. • Lead and perform OOS/OOE investigations, deviation investigation /CAPA implementation and ensure timely closure. Evaluates/troubleshoots routine and non-routine technical and analytical problems and assists other laboratories and/or manufacturing in specific investigations. Handle change control and ensure timely closure.
• Supports the development, revision, application, maintenance, validation and review of quality standards, documents and methods for processing and/or ensuring quality in intermediates or finished products. Review and approval of batch documentation. Ensure conformance to in-house specifications and GMPs. Maintain all test methods and specifications compliant with current USP/NF.
• Possess CSV validation experience/documentation experience. Authors method validation protocols and reports. Performs method revision and validation as well as assisting with method development Authors new and revises existing standard operating procedures to ensure compliance. Perform review and release of test work. Leads method revision and transfers.
• Execute periodic, mid-year/year-end performance appraisals for direct reports. Leads training of new associates. Provides feedback (formal and informal) to team members on routine basis. Perform other duties as assigned.
• Work on shifts covering daytime / evening and one or both weekend days. Ability to work different shift, weekends and overtime will be required. Your shift will be fixed according to business need.
• Knowledge and familiarity of SAP systems, including Quality Module (QM), LIMS systems (Labware LIMS), Trackwise, and familiarity of eSOPS and TEDI. Drive 5S and lean projects. Leads optimization of test procedures to improve efficiency whenever possible.
The Senior Manager, Science & Technology (Bioanalytics) will coordinate and lead all activities to ensure the timely testing/release of all samples, set up laboratory planning to improve efficiency/throughput, lead the execution of validation and other major projects to assure GMP beyond compliance related to development/clinical operations at our Cell and Gene Therapy GMP facility! They will lead a group of lab associates and provide employees with training and resources to meet or exceed requirements. As the subject matter expert on specific areas and techniques, they will deliver quality products and services on time to all customers (internal and external); all while supervising processes and products to find opportunities for continuous improvements.
**Onsite 100% is required for this position. The schedule for this role is Wednesday - Saturday 4/10 hour days **
Your responsibilities will include, but are not limited to:
• Supervise, lead and perform scheduling of bioanalytical testing such as Flow, cell count, cell viability, Potency and qPCR following appropriate protocols, test methods, and compendia (United States Pharmacopoeia (USP), American Chemical Society (ACS)). Ensure all samples and reagents have been prepared, tested or inspected according to specifications and current testing. Assure qualification status of critical reagents.
• Primary point of contact for troubleshooting / Communication to Management during shifts. Organizes plans and provides support to the team members in any analytical/technical questions and problems, in order to ensure efficiency and accountability of the group. • Lead and perform OOS/OOE investigations, deviation investigation /CAPA implementation and ensure timely closure. Evaluates/troubleshoots routine and non-routine technical and analytical problems and assists other laboratories and/or manufacturing in specific investigations. Handle change control and ensure timely closure.
• Supports the development, revision, application, maintenance, validation and review of quality standards, documents and methods for processing and/or ensuring quality in intermediates or finished products. Review and approval of batch documentation. Ensure conformance to in-house specifications and GMPs. Maintain all test methods and specifications compliant with current USP/NF.
• Possess CSV validation experience/documentation experience. Authors method validation protocols and reports. Performs method revision and validation as well as assisting with method development Authors new and revises existing standard operating procedures to ensure compliance. Perform review and release of test work. Leads method revision and transfers.
• Execute periodic, mid-year/year-end performance appraisals for direct reports. Leads training of new associates. Provides feedback (formal and informal) to team members on routine basis. Perform other duties as assigned.
• Work on shifts covering daytime / evening and one or both weekend days. Ability to work different shift, weekends and overtime will be required. Your shift will be fixed according to business need.
• Knowledge and familiarity of SAP systems, including Quality Module (QM), LIMS systems (Labware LIMS), Trackwise, and familiarity of eSOPS and TEDI. Drive 5S and lean projects. Leads optimization of test procedures to improve efficiency whenever possible.