394757BR
Mar 19, 2024
USA
About the Role
10 days, that is how long we treat a patient’s T-cells, before we return them to potentially save this patient’s life.
To support such novel, personalized treatment by defining and implementing the microbial control strategy, is a unique challenge within Novartis with immediate patient impact.
As a member of the Technical Development group, this individual will manage and own current and future Cell and Gene development projects and contribute to interdisciplinary technical development work in the larger CGT organization. The candidate will act as a subject matter expert for cell therapies projects, interpret and communicate results, evaluate data, draw relevant conclusions and write protocols, reports, and other source documents for regulatory submissions. Contribute to risk analyses and/or peer review and process challenge meetings.
Your responsibilities will include, but are not limited to:
• Provide scientific/technical leadership for developing, optimizing and validating efficient and robust processes to manufacture cell-based therapeutics.
• Perform experimental design, protocol development and execution, data analysis, technical report writing and presentation.
• Assume scientific/technical key function in teams, projects, networks, platforms and/or department activities.
• Collaborate with cross-functional teams, including analytical, quality assurance, technical operations and regulatory to establish robust manufacturing processes that comply with GMP and regulatory requirements
• Contribute to technology transfer, comparability, process characterization, process validation and troubleshooting
• Contribute to Quality risk management assessment and mitigation efforts to meet Quality target Product Profile (QTPP) and Target Product Profile (TPP)
• Define process operating ranges, acceptable ranges for process understanding and performance optimization, perform gap analysis/failure mode effect and analysis (FMEA)
• Deliver on project milestones, including technical presentations, development reports and other documents relevant to GMP operations.
• Adherence to Novartis standards, in particular, quality, ethical, health, safety, and environment (HSE), and information security (ISEC) standard
• Measurable contributions to the success, efficiency and productivity of the department and new programs/initiatives started and implemented. Contributes to management decision making and advisory boards.
Accessibility and reasonable accommodations
The 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 [email protected] call +1 (877)395-2339 and let us know the nature of your request and your
To support such novel, personalized treatment by defining and implementing the microbial control strategy, is a unique challenge within Novartis with immediate patient impact.
As a member of the Technical Development group, this individual will manage and own current and future Cell and Gene development projects and contribute to interdisciplinary technical development work in the larger CGT organization. The candidate will act as a subject matter expert for cell therapies projects, interpret and communicate results, evaluate data, draw relevant conclusions and write protocols, reports, and other source documents for regulatory submissions. Contribute to risk analyses and/or peer review and process challenge meetings.
Your responsibilities will include, but are not limited to:
• Provide scientific/technical leadership for developing, optimizing and validating efficient and robust processes to manufacture cell-based therapeutics.
• Perform experimental design, protocol development and execution, data analysis, technical report writing and presentation.
• Assume scientific/technical key function in teams, projects, networks, platforms and/or department activities.
• Collaborate with cross-functional teams, including analytical, quality assurance, technical operations and regulatory to establish robust manufacturing processes that comply with GMP and regulatory requirements
• Contribute to technology transfer, comparability, process characterization, process validation and troubleshooting
• Contribute to Quality risk management assessment and mitigation efforts to meet Quality target Product Profile (QTPP) and Target Product Profile (TPP)
• Define process operating ranges, acceptable ranges for process understanding and performance optimization, perform gap analysis/failure mode effect and analysis (FMEA)
• Deliver on project milestones, including technical presentations, development reports and other documents relevant to GMP operations.
• Adherence to Novartis standards, in particular, quality, ethical, health, safety, and environment (HSE), and information security (ISEC) standard
• Measurable contributions to the success, efficiency and productivity of the department and new programs/initiatives started and implemented. Contributes to management decision making and advisory boards.
Accessibility and reasonable accommodations
The 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 [email protected] call +1 (877)395-2339 and let us know the nature of your request and your
Diversity & Inclusion / EEO
We are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.
Accessibility and Reasonable Accommodations: Individuals in need of a reasonable accommodation due to a medical condition or disability for any part of the application process, or to perform the essential functions of a position, please let us know the nature of your request, your contact information and the job requisition number in your message:
Accessibility and Reasonable Accommodations: Individuals in need of a reasonable accommodation due to a medical condition or disability for any part of the application process, or to perform the essential functions of a position, please let us know the nature of your request, your contact information and the job requisition number in your message:
- Novartis: e-mail [email protected] or call +1 (877)395-2339
- Sandoz: e-mail [email protected] or call: +1-609-422-4098
Role Requirements
What you'll bring to the role:
• Bachelor's degree with 8+ years of industry experience, or Master's degree with 5+ years of industry experience, or a PhD with 3+ years relevant experience in Immunology/Cell Therapy space.
• Robust scientific background and understanding of CAR-T manufacturing and process development under cGMP processes. Experience and working knowledge of T-cells or immunological cell therapies required.
• Experience supporting autologous cell therapy process development, process scale up, optimization and manufacturing along with process characterization and late-stage development is highly desired.
• Experience with functionally closed systems/ early technological evaluations for large-scale autologous or allogenic CAR-T cell processing is highly desirable.
•Experience with cell culture processing systems such as Sepax, CliniMACS Prodigy and LOVO.
• Demonstrated ability for critical thinking and innovation, able to understand and communicate risks, and develop and execute contingency plans. Highly organized and efficient, able to work independently.
• Demonstrated record of accomplishment in fostering innovation and creative problem-solving.
• Experience leading a project, reviewing data and interpreting collective data sets and troubleshooting.
• Proven leadership skills, demonstrated history of working on team-oriented projects, managing team members.
• Good communication/presentation skills and scientific/technical writing skills.
The pay range for this position at commencement of employment is expected to be between $124,000 and $186,000 year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
Why Novartis?
799 million. That’s how many lives our products touch. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?
We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.
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.
• Bachelor's degree with 8+ years of industry experience, or Master's degree with 5+ years of industry experience, or a PhD with 3+ years relevant experience in Immunology/Cell Therapy space.
• Robust scientific background and understanding of CAR-T manufacturing and process development under cGMP processes. Experience and working knowledge of T-cells or immunological cell therapies required.
• Experience supporting autologous cell therapy process development, process scale up, optimization and manufacturing along with process characterization and late-stage development is highly desired.
• Experience with functionally closed systems/ early technological evaluations for large-scale autologous or allogenic CAR-T cell processing is highly desirable.
•Experience with cell culture processing systems such as Sepax, CliniMACS Prodigy and LOVO.
• Demonstrated ability for critical thinking and innovation, able to understand and communicate risks, and develop and execute contingency plans. Highly organized and efficient, able to work independently.
• Demonstrated record of accomplishment in fostering innovation and creative problem-solving.
• Experience leading a project, reviewing data and interpreting collective data sets and troubleshooting.
• Proven leadership skills, demonstrated history of working on team-oriented projects, managing team members.
• Good communication/presentation skills and scientific/technical writing skills.
The pay range for this position at commencement of employment is expected to be between $124,000 and $186,000 year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
Why Novartis?
799 million. That’s how many lives our products touch. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?
We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.
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.
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
Development
TECHNICAL R & D GDD
USA
East Hanover, NJ
Novartis Pharmaceuticals
Research & Development
Full Time
Regular
No
394757BR