Address
Form of workAbout the role
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.
As a key member of the Cell Therapies Process Development leadership team, this individual and his/her team will be accountable for Process Development activities for current and future programs including/not limited to Process Development/optimization, technology transfers (internal and external), manufacturing support, and development of source documents for regulatory filings. Deep expertise in the field of Process Development for cell therapies is essential. Growth mentality and passion to serve patients, his/her technical team and development programs, and demonstrated people leadership is a must.
Your responsibilities will include, but are not limited to:
• Provide strategic, technical and scientific leadership to the cell Process Development team, to develop, optimize, and characterize robust Cell Therapy Processes and new technology evaluation and implementation.
• Collaborate closely with peer function teams and communicate complex technical topics and decisions within the department and to program teams and provide effective technical and business leadership at the R&D as well as the technical operations interface.
• Ensure seamless transition of unit operations from bench-scale to clinical scale, and from open to closed manufacturing systems to develop a robust process control strategy.
• Work collaboratively with Process Development leadership to develop and/or optimize Cell Therapy platforms (T cells and Stem cell therapies), to support Novartis Cell Therapy's multi-product portfolio of clinical development programs.
• Provide strategic leadership and influence for the development and tech transfer of process platforms to support manufacturing of Cell Therapy products across a network of internal and external manufacturing sites.
• Develop, lead and coach a group of engineers/scientists through direct supervision and/or as matrix leader.
• Author and review regulatory submissions and responses to questions from health authorities.
Role Requirements
What you'll bring to the role:
• PhD or equivalent in Cell Biology / Immunology / Bioprocessing or related scientific field.
• >9 years of relevant experience in process and medium development for
processing for primary cells (T-cells, stem cells) for autologous and/or allogeneic cell production is strictly required.
• Strong fundamental knowledge of cell biology, immunology and existing cell culture process technology is expected. Proven track record in utilization of special tools/equipment, lab automation tools and specialized facilities. Hands-on interest and experience with respective analytical methods is preferred.
• Demonstrated experience leading Process Development initiatives in support of cell therapies, or protein biologics manufacturing, early- and late-stage.
• Proficiency in strategic planning, team dynamic management, and technical leadership.
• Proven leadership experience and strong people management skills with the desire and ability to deliver on objectives while developing people in a fast-paced environment.
The pay range for this position at commencement of employment is expected to be between $136,800 and $205,200 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.
EEO Statement
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:
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.
As a key member of the Cell Therapies Process Development leadership team, this individual and his/her team will be accountable for Process Development activities for current and future programs including/not limited to Process Development/optimization, technology transfers (internal and external), manufacturing support, and development of source documents for regulatory filings. Deep expertise in the field of Process Development for cell therapies is essential. Growth mentality and passion to serve patients, his/her technical team and development programs, and demonstrated people leadership is a must.
Your responsibilities will include, but are not limited to:
• Provide strategic, technical and scientific leadership to the cell Process Development team, to develop, optimize, and characterize robust Cell Therapy Processes and new technology evaluation and implementation.
• Collaborate closely with peer function teams and communicate complex technical topics and decisions within the department and to program teams and provide effective technical and business leadership at the R&D as well as the technical operations interface.
• Ensure seamless transition of unit operations from bench-scale to clinical scale, and from open to closed manufacturing systems to develop a robust process control strategy.
• Work collaboratively with Process Development leadership to develop and/or optimize Cell Therapy platforms (T cells and Stem cell therapies), to support Novartis Cell Therapy's multi-product portfolio of clinical development programs.
• Provide strategic leadership and influence for the development and tech transfer of process platforms to support manufacturing of Cell Therapy products across a network of internal and external manufacturing sites.
• Develop, lead and coach a group of engineers/scientists through direct supervision and/or as matrix leader.
• Author and review regulatory submissions and responses to questions from health authorities.
Role Requirements
What you'll bring to the role:
• PhD or equivalent in Cell Biology / Immunology / Bioprocessing or related scientific field.
• >9 years of relevant experience in process and medium development for
processing for primary cells (T-cells, stem cells) for autologous and/or allogeneic cell production is strictly required.
• Strong fundamental knowledge of cell biology, immunology and existing cell culture process technology is expected. Proven track record in utilization of special tools/equipment, lab automation tools and specialized facilities. Hands-on interest and experience with respective analytical methods is preferred.
• Demonstrated experience leading Process Development initiatives in support of cell therapies, or protein biologics manufacturing, early- and late-stage.
• Proficiency in strategic planning, team dynamic management, and technical leadership.
• Proven leadership experience and strong people management skills with the desire and ability to deliver on objectives while developing people in a fast-paced environment.
The pay range for this position at commencement of employment is expected to be between $136,800 and $205,200 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.
EEO Statement
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:
- Novartis: e-mail us.reasonableaccommodations@novartis.com or call +1 (877)395-2339
- Sandoz: e-mail reasonable.accommodations@sandoz.com or call: +1-609-422-4098
