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Senior Expert Science & Technology, Analytical Development

3-8 years
$114,100.00 - $211,900.00
10 Jan. 31, 2025
Job Description
Job Type: Full Time Education: B.Sc,M.Sc,B.Pharma,M.Pharma,LifeScience Graduates Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Senior Expert Science & Technology – Analytical Development

Company: Novartis

Location: East Hanover, NJ (Onsite)

Job Type: Full-time

Application Deadline: February 4, 2025

Job ID: REQ-10024883


About the Role

This is an exciting opportunity to contribute to cutting-edge CAR-T cell therapy development. As a Senior Expert in Science & Technology, you will lead the development, optimization, and implementation of novel analytical methodologies to characterize cell therapy products. You will collaborate with a talented and experienced team within the Technical Research and Development organization, driving innovation from bench to bedside.

This role requires scientific leadership, technical expertise, and a deep understanding of method suitability for Quality Control (QC) implementation. The successful candidate will work on cross-functional projects supporting process development, characterization, and method validation in a Good Laboratory Practice (GLP) / Good Manufacturing Practice (GMP) environment.


Key Responsibilities

Analytical Development & Method Optimization

  • Design and develop complex cellular characterization and potency assays for cell therapy products.
  • Lead method qualification, optimization, transfer, and implementation across relevant project teams.
  • Stay updated with next-generation analytical technologies for cell therapies.

Regulatory & Quality Compliance

  • Maintain meticulous records in electronic laboratory notebooks, ensuring GLP/GMP compliance.
  • Contribute to tracking and trending systems to enhance quality control and efficiency.
  • Author and review technical and regulatory documents for accuracy and consistency.

Cross-functional Collaboration

  • Support process development and characterization through robust analytical testing.
  • Provide scientific expertise to Quality Control (QC) units for method implementation.
  • Work closely with R&D, regulatory, and manufacturing teams to ensure analytical success.

Continuous Improvement & Innovation

  • Identify areas for improvement with tangible solutions and implementation strategies.
  • Utilize cutting-edge methodologies to enhance cell therapy product testing.

Qualifications & Experience

Educational Background

  • BS, MS, or Ph.D. in Biology, Chemistry, Biochemistry, Immunology, or a related scientific field.

Industry Experience

  • 8+ years (BS), 5+ years (MS), or 3+ years (Ph.D.) of experience in assay development within the cell and gene therapy field.
  • Expertise in cellular-based analytical methods, including ELISA, MSD, and cell-based assays.

Technical Skills & Expertise

  • Strong hands-on experience with aseptic techniques and mammalian cell culture.
  • Human T-cell culture experience is required.
  • Knowledge of GLP/GMP quality systems and regulatory compliance.
  • Proficiency in scientific data analysis, problem-solving, and decision-making.

Soft Skills & Communication

  • Ability to present complex data to cross-functional teams.
  • Strong scientific writing and technical documentation skills.
  • Detail-oriented, self-motivated, and proactive in continuous improvement initiatives.

Preferred Qualifications

  • Experience in writing Standard Operating Procedures (SOPs) and technical instructions.

Compensation & Benefits

Salary Range

💰 $114,100 - $211,900 (based on experience, location, and expertise).

Additional Benefits

Sign-on bonus & stock options (based on eligibility).
Comprehensive health & financial benefits, including 401(k) plans.
Paid time off, including vacation, sick leave, and parental leave.
Opportunities for professional growth and development.


Why Join Novartis?

At Novartis, we are committed to developing life-changing therapies and fostering an environment of innovation, collaboration, and inclusivity. As a global leader in cell and gene therapy, we provide the resources, support, and career development opportunities you need to make a meaningful impact.

Explore more about our culture and values:
🌍 Novartis Careers
📘 Benefits & Rewards


Diversity & Inclusion

Novartis is an Equal Opportunity Employer, committed to fostering a diverse and inclusive workplace. We do not discriminate based on race, gender, age, disability, sexual orientation, or any other legally protected status.

For reasonable accommodations in the application process, contact:
📧 us.reasonableaccommodations@novartis.com
📞 +1 (877) 395-2339


Join Our Talent Network

🚀 If this role isn't the perfect fit, stay connected with Novartis career opportunities:

🔗 Join the Novartis Talent Community


Desired Skills

  • Coaching & Mentorship
  • Data Science & Experiment Design
  • GLP/GMP Compliance & Laboratory Standards
  • Technical Writing & SOP Development
  • Process Simulation & Manufacturing Knowledge
  • Health & Safety (EHS) Best Practices

Ready to revolutionize cell therapy? Apply now! 🎯