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Senior Expert Science & Technology, Analytical Development

3-8 years
$114,100 - $211,900
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

Job Title: Senior Expert Science & Technology – Analytical Development

Location: East Hanover, NJ (Onsite)
Job Type: Full-time
Application Deadline: February 4, 2025


Job Summary:

Novartis is seeking a Senior Expert in Science & Technology to support CAR-T cell therapy development by designing, optimizing, and implementing advanced analytical methodologies. This role will be based at our Technical Research and Development organization in East Hanover, NJ and will contribute to process development, characterization, and Quality Control implementation.

The ideal candidate will bring scientific leadership, expertise in cellular characterization assays, and experience working in a regulated environment (GMP/GLP).


Key Responsibilities:

Analytical Method Development & Implementation:

  • Independently design, develop, and optimize cellular characterization and potency assays for CAR-T cell therapy products.
  • Lead and drive method qualification, optimization, transfer, and implementation activities.
  • Ensure analytical methods meet suitability standards for Quality Control (QC) implementation.
  • Maintain accurate documentation in electronic laboratory notebooks (ELN) in compliance with GLP/GMP standards.

Innovation & Cross-functional Collaboration:

  • Stay up to date with emerging analytical technologies for cell therapies and apply innovative solutions.
  • Contribute to process development, characterization, and manufacturing support.
  • Participate in cross-functional activities, supporting regulatory filings and technical documentation.
  • Author and review technical reports, standard operating procedures (SOPs), and regulatory documents.

Quality, Compliance & Process Improvement:

  • Ensure compliance with GMP/GLP quality systems.
  • Identify areas for process improvement and implement practical solutions.
  • Support tracking and trending systems to evaluate quality and efficiency.

Qualifications & Experience:

Education & Industry Experience:

  • BS, MS, or Ph.D. in Biology, Chemistry, Biochemistry, Immunology, or a related field.
  • Industry experience in assay development for cell and gene therapy:
    • 8+ years (BS)
    • 5+ years (MS)
    • 3+ years (Ph.D.)

Technical & Scientific Expertise:

  • Strong understanding of cell-based analytical methods (ELISA, MSD, and cell-based potency assays).
  • Expertise in mammalian cell culture and aseptic techniques.
  • Human T-cell culture experience is required.
  • Strong ability to present complex data and communicate scientific concepts.
  • Experience working in a regulated environment (GMP/GLP, Quality Control, compliance).

Preferred Experience:

  • Experience writing SOPs and technical instructions.
  • Strong problem-solving skills and decision-making abilities.
  • Effective collaboration with cross-functional teams in a fast-paced setting.

Skills & Competencies:

  • Analytical Method Development & Validation
  • Cell-based Assays (ELISA, MSD, Flow Cytometry, PCR)
  • GMP/GLP Compliance & Quality Control
  • Process Optimization & Manufacturing Support
  • Technical Writing & Regulatory Documentation
  • Laboratory Equipment & Safety
  • Coaching & Mentorship
  • Data Science & Experimental Design

Languages Required:

  • English (Fluent)

Why Join Novartis?

  • Innovative Science: Be part of cutting-edge CAR-T cell therapy research and development.
  • Professional Growth: Opportunities for career advancement and leadership in analytical development.
  • Global Impact: Work on life-changing therapies for patients in need.
  • Diverse & Inclusive Culture: Join a collaborative, supportive, and innovative work environment.

🚀 Help us transform medicine and make a difference in patients’ lives!


Compensation & Benefits:

💰 Salary Range: $114,100 - $211,900 (Final offer based on experience, skills, and location)
🎁 Additional Benefits:

  • Sign-on bonus (as applicable)
  • Restricted stock units & discretionary awards
  • Medical, dental, vision & 401(k) plans
  • Paid time off (vacation, sick leave, parental leave, etc.)

🔗 Learn more about Novartis Benefits & Rewards: Novartis Careers


Commitment to Diversity & Inclusion:

Novartis is an Equal Opportunity Employer dedicated to building diverse and inclusive teams. We encourage applications from individuals of all backgrounds, experiences, and abilities.

📢 Join our Talent Network: If this role isn't the right fit, stay updated on future career opportunities by signing up here: Novartis Talent Network

📌 Note: Visa sponsorship is not available for this position.

#Novartis #CAR-T #AnalyticalDevelopment #CellTherapy #GMP #Biotechnology #Immunology #CellCulture