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.
The Expert Science & Technology will support all drug product development efforts including but not restricted to: formulation development, stability assessments, and technical management of external vendors. Routinely applies scientific/technical expertise to address complex drug product issues and actively support Technical Development strategies and goals by participating in cross-functional teams. Experience working with Quality systems. Knowledgeable of requirements associated with Drug Product for regulatory filings (i.e. extractables & leachables, container closure integrity, in-use stability, etc.).
Your responsibilities will include, but are not limited to:
• Function as a technical expert within the Technical Development organization, this individual will be accountable for Drug Production development activities for current and future Cell Therapy (CT) projects.
• He/She will contribute to key technical activities including technology transfers (internal and external), manufacturing support, and development of source documents for regulatory filings. Deep expertise in the field of drug product considerations and regulatory requirements.
• Additionally, this role will contribute to interdisciplinary technical development initiatives for cell therapy projects.
• This role is expected to regularly interface with external partners, monitoring outsourced activities and ensuring deliverables according to Novartis standards.
• As a technical expert, he/she will actively participate in several technical forums.
• The candidate will act as a subject matter expert for drug product considerations for cell therapies; interpreting and communicating results, evaluating data, draw relevant conclusions, and write reports and regulatory documents.
Diversity & Inclusion / EEO
The Novartis Group of Companies 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.
What you'll bring to the role:
• A degree in Cell Biology / Biochemistry or related scientific discipline with BS + 3 years experience, MS + 2 years experience, or PHD graduate with academic studies
• Deep experience in drug product development with particular experience in cell therapies (T-cells, stem cells)
• Fundamental knowledge of cell biology, immunology and existing technologies 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.
• Knowledge and practical experience in statistics is expected. GMP experience and a strong knowledge of relevant regulatory guidelines(FDA, EMEA, ICH) is preferred.
• Further requirements include team player with strong communication (verbal and written) and an established track record of working effectively in a matrix environment.
The pay range for this position at commencement of employment is expected to be between $97,600 and $146,400 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.
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 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 contact information. Please include the job requisition number in your message.