Senior Expert Science & Technology, Potency, Analytical Development

Job Description Summary

This position will be located at East Hanover, NJ site and will not have the ability to be located remotely.

Internal Title: Senior Expert Science & Technology

Bench to bedside! This exciting role serves as a Senior Expert Science & Technology 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 successful candidate will own and drive technical development projects designed for release and characterization of cell therapy product potency 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 routine testing labs, including 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.

 

Job Description

Key Responsibilities:

• Independently design and develop complex cellular characterization and potency assays for cell therapy products.
• Lead, own, and drive potency method development, optimization, qualification, transfer, and implementation activities, along with the relevant project-specific sub-teams
  Actively keep abreast with the latest advances in next-generation analytical technologies for cell therapies
• Record and maintain meticulous records in electronic laboratory notebook in compliance with GLP/GMP standards
• Continually identify areas for improvement with tangible solutions and implementation approaches
• 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

Requirements:

• A Bachelor's Master's or Ph.D. in biology, chemistry, biochemistry, immunology or other related science.
• Minimum of 8+ (Bachelor's), 5+ (MS) or 3+ (Ph.D.) years of industry experiences in assay development in biologics potency or in cell and gene therapy field analytical development.
• Understanding of the scientific principles underpinning of cellular based analytical methods including ELISA and Cell-based assays
• Expertise with aseptic technique and mammalian cell culture including suspension cells.
• 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
  Good presentation skills and scientific/technical writing skills

Desired Requirement:

• Human T-cell culture experience is desirable
• Experience writing laboratory SOPs and technical instructions is preferred
• Direct experience with GMP is a plus
• Experience with biophysical techniques (eg. HPLC, SPR, LC-MS) is a plus
• Late stage experience preferred

Novartis Compensation and Benefit Summary: The pay range for this position at commencement of employment is expected to be between $114,100-$211,9000; 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 perfor