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Senior Expert, Science & Technology - Virology

Company: Novartis Gene Therapies
Location: Durham
Posted on: January 15, 2022

Job Description:

Imagine... 2 weeks after the birth of your child you realize they aren't meeting critical developmental milestones and after months of doctor's appointments you are told your baby has a rare neurological disease that would impact how they would live their lives. This is the reality of parents whose children have Spinal Muscular Atrophy (SMA) and it's the reason why we at Novartis Gene Therapy are laser focused on bringing hope and possibility to those devastated by rare genetic diseases. We use cutting-edge technology to turn promising gene therapies into proven treatments beginning with SMA but also focusing on Rett Syndrome and Friedreich's Ataxia. Imagine the lives you could transform by joining the Novartis Gene Therapy team.-- -The Senior Expert, Science & Technology - Virology, leads laboratory operations in process design, experimental design & execution, scale model development, investigational testing for operations support as well as platform development project planning, execution, and therapeutic product program development from a Virological perspective.-- - Responsibilities Process development activities leveraging viral knowledge in drug substance (upstream, intermediate and downstream), drug product (formulation, filling, packaging and labeling) and critical raw materials, as well as media and buffer manufacturing; opportunity to collaborate in the multiple technical development areas.Executes and documents experimental procedures in support of process development activities supporting investigational, clinical and commercial gene therapy programs including but not limited to new process design, process proof of concept through characterization studies in alignment with program strategy, pre-clinical materials generation, direct clinical and commercial GMP operations support, scale-up studies scale model demonstration through qualification, raw materials and process pool evaluations.Serves as the SME in technical team discussions of how process changes will affect the virus/vector and makes recommendations/conducts experiments to mitigate and investigate how the vector will be affected. Advises on, and as needed directs, the activity of scientific & engineering staff. This position may have up to 1-5 direct reports.Advances complex upstream process development efforts as a technical lead within a cross-functional team across geographic sites.Leads projects within the technical development unit to enhance AAV/lentivirus production and capture technology capability and performance.Independently designs/executes and/or directs development studies relating to vector and cargo while ensuring individual experiments balance time and resources.Drives results and generates innovative solutions, takes independent action to solve scientific problems and drive their resolution.Supports and advises active pre-clinical, clinical and commercial manufacturing through laboratory studies designed to illuminate fundamental process performance (e.g. NOR & PAR setting, CPP edge of failure, impurity clearance performance).Independently authors technical reports of studies in support of process development activities such as Tech Transfer, unit operation design through characterization and quality attribute impact assessments.Ensures all documentation and reports are accurate, complete, and suitable for use in support of platform development summary reporting, manufacturing records development as well as quality investigations and regulatory dossiers.Analyzes and interprets data to understand the fundamental phenomena at the heart of the investigation at hand and inform next steps.Troubleshoots scientific and technical challenges, contributes to and/or leads their resolution. Leads and mentor junior colleagues while fostering a team environment committed to the principles of scientific excellence.Completes requisite training, as well as applicable policies and procedures, related to the job functionServe as a biosafety expert for internal safety programs with regard to impact of virus/vector risk to personnel. Other related job duties as assigned. Qualifications Bachelor's degree in relevant field with 8 years' experience, Master's degree , in relevant field, with 6 years' experience or PHD, in relevant field with 4 years' experience.Advanced degree in in virology, molecular biology, genetics or related technical field is strongly preferred. Expert knowledge of scientific principles and concepts.-- -Reputation as emerging leader in field with sustained performance and accomplishment. Expertise and perspective to process development and the ability to leverage a deep knowledge of recombinant/molecular/reverse genetic approaches to virus production.Proven ability to lead/influence broad technical teams in a matrix environment is required for this role.In-depth knowledge of AAV/virus based product/process development including transfection development, scale-up, and significantly improving process performance.Experience and leadership in the area of biosafety, NIH biosaftey guidelines, and the ability to lead and perform complex biosafety assessments for new viruses/processes is required.Experience with a variety of mammalian cell culture bioreactor technologies, adherent and suspension, including fed batch and perfusion, is preferred.Experience in the laboratory setting with single use and automated bioreactors (e.g. AMBR 250/15).In-depth knowledge and understanding of virus/cell culture in clinical and commercial manufacturing settings, direct experience in those environments preferred.Experience in how to develop, optimize, and leverage scale models of biopharmaceutical processes. Advanced understanding of macroscopic kinetic models of mammalian cells preferred.Understanding of, and experience with, global regulations pertaining to cGMP manufacturing of Drug Substance and/or Drug Product and the translation of those regulations into process development work products.Indirect and direct leadership of, and participation on, complex, multi-disciplinary technical teams of scientists and engineers tasked with rapid and comprehensive development of new biopharmaceutical manufacturing platforms.Up to 50% laboratory work is required for this role. Demonstrated experience with Design of Experiment concepts preferred.May require up to 10% travel when necessary.Why Novartis?769 million lives were touched by Novartis medicines in 2020, 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!-- -Novartis Gene Therapies Benefit Summary:Annual bonus, long term incentive, health insurance, paid vacation/holidays, potential flexible working arrangements (based on role) and an employee recognition program are available for this position, among many other benefits provided to employees of Novartis Gene Therapies.-- -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.-- -Novartis Gene Therapies is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status..-- --- -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-- - 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.-- -#LI-AR1 Need help finding the right job? We can recommend jobs specifically for you! Click here to get started.

Keywords: Novartis Gene Therapies, Durham , Senior Expert, Science & Technology - Virology, IT / Software / Systems , Durham, North Carolina

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