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Senior Expert Science & Technology, Potency, Analytical Development

Novartis
Full-time
On-site
East Hanover, NJ
Clinical Research and Development

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Role Summary

Senior Expert Science & Technology to develop, optimize, and implement novel analytical methodologies for CAR-T cell therapy products. Own and drive technical development projects designed for release and characterization of cell therapy product potency; contribute to cross-functional activities including process development, process characterization, and method implementation in routine testing labs, including Quality Control Units.

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; stay current with advances in analytical technologies for cell therapies.
  • Record and maintain meticulous records in electronic laboratory notebook in compliance with GLP/GMP standards.
  • Continuously identify areas for improvement with tangible solutions and implementation approaches.
  • Knowledge of GMP/GLP quality systems.
  • Support tracking and trending systems and programs to assist in testing, evaluation, and monitoring of quality and efficiency.
  • Author and review technical and regulatory documents to ensure completeness, accuracy, clarity.

Qualifications

  • Education: Bachelor’s, Master’s, or Ph.D. in biology, chemistry, biochemistry, immunology, or related science.
  • Experience: 8+ years (Bachelor’s), 5+ years (MS), or 3+ years (Ph.D.) of industry experience in assay development in biologics potency or cell and gene therapy analytical development.
  • Principles: Understanding of cellular-based analytical methods including ELISA and cell-based assays.
  • Technical: Expertise with aseptic technique and mammalian cell culture including suspension cells.
  • Communication: Ability to present complex data and communicate clearly with cross-functional teams.
  • Attention to detail: Problem solving and solid decision-making abilities; written and presentation skills in a regulated environment.

Skills

  • Analytical method development for potency and cellular characterization.
  • GLP/GMP compliant documentation and record-keeping.
  • Cross-functional collaboration and scientific/technical writing.

Education

  • Bachelor’s, Master’s, or Ph.D. in biology, chemistry, biochemistry, immunology, or related science.

Additional Requirements

  • Desirable: Human T-cell culture experience.
  • Desirable: Experience writing laboratory SOPs and technical instructions.
  • Desirable: Direct experience with GMP; experience with biophysical techniques (HPLC, SPR, LC-MS); late-stage experience.
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