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Expert - Technical Development Cell Therapy Process Development

Novartis Group Companies
parental leave, paid time off, sick time, 401(k)
United States, New Jersey, East Hanover
Feb 21, 2025

Job Description Summary

As a member of the Technical Development Cell Therapy Process Development group, this individual will support and execute 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, execute cell therapy process development studies, 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.

Job Description

What you will be doing:

  • Perform experimental design, protocol development and execution, data analysis, technical report writing and presentation.

  • Execution of cell therapy process development studies at large and small scale, including material thawing, cell enrichment, viral transduction, cell culturing and product formulation.

  • Provide scientific/technical leadership for efficient and robust processes for the manufacture and/or analysis of intermediates, drug substances and drug products as per own discipline.

  • Report and present of scientific/technical work at internal/external meetings/conferences and publish in peer reviewed international scientific journals including patents.

  • Assume scientific/technical key function in teams, projects, networks, platforms and/or department activities.

  • Delivery 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) standards.

  • Feedback from other team leaders and advisory boards.

  • Refer to annual individual and team objective setting.

  • Outcome of risk analyses, process challenge meetings, audits and inspections.

  • Measurable contributions to the success, efficiency and productivity of the department and new programs/initiatives started and implemented.

  • Based on project needs support for executing studies outside of standard business hours needed for this role.

What you will bring to the role;

  • Bachelor's degree with 3-5 years of industry experience OR Master's degree with 2-3 years of industry experience

  • Degree in Biology, Microbiology, Biomedical Engineering, Biochemical/Chemical Engineering, or Relevant Field

  • Scientific background and understanding of CAR-T manufacturing and development process scale up and scale down

  • 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 record of accomplishment in fostering innovation and creative problem-solving

  • Experience with primary cell isolation and maintenance.

  • Demonstrated history of working on team-oriented projects, managing team members

  • Strong communication/presentation skills and scientific/technical writing skills.

Novartis Compensation and Benefit Summary: The pay range for this position at commencement of employment is expected to be between: $93,800 and $174,200/year; however, while salary ranges are effective from 1/1/25 through 12/31/25, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills, and abilities. 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.

Commitment to Diversity & Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve

EEO Statement:

The Novartis Group of Companies are Equal Opportunity Employers who are focused on building and advancing a culture of inclusion that values and celebrates individual differences, uniqueness, backgrounds and perspectives. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to fostering a diverse and inclusive workplace that reflects the world around us and connects us to the patients, customers and communities we serve.

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 to perform the essential functions of a position, please send an e-mail to us.reasonableaccommodations@novartis.com or 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.

Salary Range

$93,800.00 - $174,200.00

Skills Desired

Environment, Experiments Design, Health And Safety (Ehs), Laboratory Equipment, Manufacturing Process, Materials Science, Process Simulation, Sop (Standard Operating Procedure), Technical Writing, Waterfall Model
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