Job Description Summary The Sterility Assurance Lead serves as the key functional expert for aseptic processing at the Morris Plains, NJ facility. The incumbent will be responsible for providing technical leadership, direction, and management of sterility assurance quality operations to support aseptic manufactured CGT (cell and gene therapy) products. This includes the development and optimization of current processes and programs to ensure compliance with regulatory requirements, organizational development, and making appropriate decisions and recommendations to address trends, issues, or significant observations related to sterility assurance.
Location: This position must be located on-site in Morris Plains, NJ.
Responsibilities: Provide technical leadership and expertise in sterility assurance and microbial control, ensuring compliance with cGMP and regulatory requirements.Collaborate with site operations, quality heads, Novartis representatives, and quality leaders to ensure comprehensive sterility assurance support across the site.Offer expert advice and technical support to prepare sites for regulatory and internal inspections.Lead and support investigations into microbial contamination events, establishing root causes and CAPA.Assist the team in justifying microbial controls and limits for CGT products.Support the preparation and delivery of Validation Plans, Site Quality Risk Assessments, and Quality Assessments related to sterility assurance.Provide quality input into product- or process-related deviations, change control, and audits/inspections, ensuring proper escalation and remediation of critical issues.Drive the implementation of new technologies for microbial monitoring and controls.Optimize and standardize aseptic techniques, cleaning and disinfection programs, microbiological monitoring, and sterilization techniques across network sites.Maintain up-to-date knowledge of industry technologies and regulations.Evaluate and anticipate the impact of emerging regulatory requirements in collaboration with QA and Regulatory business partners, integrating external expectations into Novartis Standards for Cell and Gene Therapies.Interact with Operations, Quality, Commercial, Clients, and relevant technical support functions within Novartis and third-party manufacturers as needed.Support cross-site/platform and network projects.Sponsor potential talents to develop the talent pipeline.Act as a role model in accordance with Novartis Values and Behaviors and leadership standards.Key Performance Indicators: Execution of responsibilities in a timely and efficient manner.Successful Health Authority Inspections.Number and severity of cGMP issues identified during internal and external audits/inspections related to aseptic processes.Follow-up actions from Health Authority Inspections including Quality programs or GMP upgrades performed in time & cGMP-compliant.Ideal Background: B.S. degree in scientific or technical field preferably in Microbiology with 6 years' experience in biopharmaceutical based GMP manufacturing operations including direct experience in managing sterility assurance programs for biotechnology manufacturing facilities.Or Master's Degree with 6 years' experience in biopharmaceutical based GMP manufacturing operations including direct experience in managing sterility assurance programs for biotechnology manufacturing facilities.Or PhD with 4 years' experience in biopharmaceutical based GMP manufacturing operations including direct experience in managing sterility assurance programs for biotechnology manufacturing facilities (Masters or PhD preferred).Skills: Deep understanding of aseptic processes.Comprehensive knowledge of FDA and EMA regulations and experience in US and international regulatory agency inspections.Excellent verbal, written communication skills and the ability to interface with multiple areas within the organization is essential.Ability to synthesize data and summarize outcomes to provide recommendations on a compliant path forward for microbial contamination events.Demonstrated ability to perform long-term project planning, team building, budgeting and operational excellence.Strong biotech background in cGMP Manufacturing of Drugs (cellular or gene therapies, proteins).Strong quality background in understanding of quality systems and regulatory requirements.Ability to work under pressure, ability to assert oneself, fast decision making, high flexibility.Salary Range: $144,000.00 - $216,000.00
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The Novartis Group of Companies are Equal Opportunity Employers who are focused on building and advancing a culture of inclusion that values and celebrates individual differences, uniqueness, backgrounds and perspectives.
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