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The Global Drug Development (GDD) organization oversees the development of new medicines discovered by our researchers and partners. We transform the lives of people by developing innovative and life-changing medicines.
Senior Expert Science & Technology - Analytical Development
Bench to bedside! This exciting role serves as a senior technical expert to develop, optimize, and implement novel analytical methodologies for our CAR-T cell therapy products. The successful candidate will work with a talented and experienced team in our Technical Research and Development organization at East Hanover, New Jersey. The Senior Expert Science & Technology role will support developmental activities. The successful candidate will own and drive technical and development projects designed to test and characterize cell therapy products through an assortment of analytical methods. This role will also contribute to cross-functional activities including supporting process development, process characterization, product characterization, and method implementation in Quality Control Units. This position requires strong scientific leadership skills and a deep understanding of method suitability for Quality Control implementation. This individual will uphold Novartis Values & Beliefs and Code of Ethics to successfully support our bold mission of delivering effective CAR-T cell products for patients in need.
What you will be doing:
• Independently design and develop complex molecular, cellular characterization, potency, multi-color flow cytometry assays for cell therapy products.
• Actively keeps a breast with the latest advances in next-generation analytical technologies for cell therapies.
• Review/approve data generated by other team members
• Lead method qualification and optimization activities
• Record and maintain meticulous records in electronic laboratory notebook in compliance with GLP/GMP standards
• Drive method transfer and implementation into Quality Control
• Collaboratively drive projects to meet established timelines while maintaining the highest quality and data integrity standards.
• Continually identify areas for improvements in project work
• Knowledge of appropriate GMP/GLP quality systems
• Support tracking and trending systems, and programs, which assist in the testing, evaluation and monitoring of quality and efficiency
• Author and review technical and regulatory documents to ensure completeness, accuracy, consistency and clarity
• Present results and project updates to team
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 will bring to the role:
• BS, MS or Ph.D in biology, chemistry, biochemistry, immunology or other related science
• 7+ (BS), 5+ (MS) or 2+ (Ph.D) years of industry experiences in assay development in cell and gene therapy field
• Understanding of the scientific principles underpinning of molecular and cellular based analytical methods including PCR, ELISA, NGS, Flow Cytometry, Cell-based assays
• Expertise with aseptic technique and mammalian cell culture, Human T-cell culture experience a plus
• Ability to present complex data and communicate clearly with a variety of cross-functional teams
• Detail-oriented with expertise in problem solving and solid decision-making abilities
• Established ability to work in a regulated environment
• Experience writing laboratory SOPs and technical instructions is preferred
• Good presentation skills and scientific/technical writing skills
The pay range for this position at commencement of employment is expected to be between $118,400 and $177,600/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.
236 million lives were touched by Novartis medicines in 2022, 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.