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Expert, Science & Technology - Analytical Method Validation

10! The number of projects you will participate in as the new Clinical Scientific Expert based at Novartis in East Hanover, New Jersey. As part of the Global Drug Development (GDD) team this role is critical in ensuring clinical trial data and Clinical Study Reports (CSR's) are of the highest quality throughout the life cycle of each project and ensure they are compliant. Your responsibilities include, but are not limited to:The Expert, Analytical Method Validation will support all activities to ensure timely and successful execution of method validation and transfer of methods. Helps with delivering quality products and services on time to all customers, internal and external. Assists with monitoring projects and products to identify opportunities for continuous improvement. Serve as the subject matter expert on specific areas and techniques. Involved in Laboratory planning to improve efficiency and throughput. Engage in projects to assure GMP beyond compliance.
• Perform the validation/qualification activities, including, Required Specifications, Qualification protocols and Reports, and Impact / Risk Assessments.
• Initiate/support review of change controls including assessment for validation impact and identification of appropriate testing to ensure maintenance of the validated state.
• Ensure the validated state of equipment, instruments, and systems supporting manufacturing is compliant with corporate policies and regulatory requirements.
• Supports external teams in qualifying new and/or replacement equipment within the laboratory
• Support execution of method qualification/development & optimization as governed by protocols and/or under the supervision of senior lab staff.
• Support technology transfer activities at internally and externally, including transfer strategy, Support transfer protocol and reports, and risk assessments. Support Operations, Quality, Technical groups, and other site/network groups as required assisting with establishing business and compliance requirements of instrumentation and processes.
• Additionally, supports the maintenance of GMP and GLP systems and environment, as well as ensures that all safety requirements are met for the lab areas.
• Assist with projects, manage own time to meet objectivesVaccine Policy: While Novartis does not require vaccination at this time, for certain Novartis sites in the US all associates and candidates may be required to either upload an image of their COVID-19 vaccine card demonstrating proof of full vaccination for COVID-19 (or other similar evidence of vaccination) or proof of a negative COVID-19 test taken by the associate or candidate within the past seven days to enter any of our sites and/or customer office or healthcare facility, as well as prior to participating in other work related off-site meetings. Employees working in customer-facing roles must adhere to and comply with customers' (such as hospitals, physician offices, etc.) credentialing guidelines, which may require vaccination. As required by applicable law, Novartis will consider requests for reasonable accommodation for those unable to be vaccinated. This requirement is subject to applicable state and local laws and may not be applicable to employees working in certain jurisdictions. Please send accommodation requests to Eh.occupationalhealth@novartis.com.What You'll Bring to the Role:
• BA or MS in Cell biology Immunology, Molecular biology, virology, biochemistry, microbiology or other related science. Advanced degree may be an advantage but not essential.
• Minimum of 3 years' experience in the pharmaceutical/Biotechnology industries conducting Method validation, tech transfers, QC testing, release testing and coordinating the activities cross functionally
• Thorough knowledge of bioassay test methods (e.g. Elisa, Flow cytometry, cell counting using NC 200, DNA extraction, qPCR, cell culture)
• Experience in the use of GxP practices relevant to analytical testing
• Minimum of 3 years' experience in the pharmaceutical/Biotechnology industries conducting Method validation, tech transfers, QC testing, release testing and coordinating the activities cross functionally
• Thorough knowledge of bioassay test methods (e.g. Elisa, Flow cytometry, cell counting using NC 200, DNA extraction, qPCR, cell culture)
• Experience in the use of GxP practices relevant to analytical testingWhy Novartis?766 million lives were touched by Novartis medicines in 2021, and while we're proud of this, we know there is so much more we could do to help improve and extend people's lives.We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working. We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world's toughest medical challenges. Because the greatest risk in life, is the risk of never trying!Imagine what you could do here at Novartis! Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.Accessibility and reasonable accommodationsThe Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to tas.nacomms@novartis.com call +1 (877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Salary: . Date posted: 06/15/2022

Expert, Science & Technology - Analytical Method Validation

East Hanover, NJ
Full time

Published on 24 Jun 2022

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