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Senior Method Expert (M/F/D) Analytical Sciences (80-100%)

10+ years
Not Disclosed
10 Jan. 30, 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 Method Expert (m/f/d) – Analytical Sciences

Job Location: Basel, Switzerland

Employment Type: Full-time (80-100%)

Role Purpose:

Novartis is seeking a highly skilled Senior Method Expert in Analytical Sciences to join the Process Analytical Sciences Team at our TRD Biologics site in Basel, Switzerland. This role focuses on developing, optimizing, and automating analytical methods for biologics drug substances and drug products, supporting projects from candidate selection to launch.

If you have expertise in analytical method development, Quality-by-Design (QbD) principles, and automation, and enjoy mentoring colleagues while working in a dynamic, cross-functional environment, this opportunity is for you.


Key Responsibilities:

1. Analytical Method Development & Optimization

  • Apply Quality-by-Design (QbD) principles to develop robust and reliable physicochemical analytical (PCA) methods.
  • Design experiments, perform risk assessments, and use statistical tools for method development.
  • Ensure appropriate trending of method performance parameters, establishing trend/control charts.

2. Advanced Instrumentation & Automation

  • Utilize state-of-the-art analytical instrumentation (HPLC/UPLC, CE, cIEF).
  • Implement miniaturization and automation to increase throughput and efficiency.
  • Explore automated platforms to streamline method development.

3. Data-Driven Approaches

  • Apply data analytics, machine learning, and modeling for method development.
  • Identify correlations between product quality attributes and method parameters to optimize method performance.

4. Regulatory Compliance & Industry Standards

  • Ensure compliance with ICH guidelines (e.g., ICH Q2(R2) and Q14) and evolving regulatory expectations.
  • Support regulatory filings with well-documented method validation strategies.

5. Cross-Functional Collaboration & Leadership

  • Work closely with research, drug substance & drug product development, quality assurance, and regulatory affairs to align analytical strategies with organizational goals.
  • Provide technical leadership, mentorship, and guidance to junior team members.

Required Qualifications & Skills:

Technical Expertise:

  • Hands-on experience with analytical instrumentation (HPLC/UPLC, CE, cIEF).
  • Senior expertise in physicochemical analytical method development.
  • Strong knowledge and application of QbD principles.
  • Experience in automation, digital tools, and data analytics.
  • Sound technical and scientific knowledge of pharmaceutical development and analytical sciences.

Industry Experience:

  • Minimum of 10 years of proven experience in the pharmaceutical industry, particularly in biotechnological CMC development.
  • Ability to work in a matrix environment, collaborating with multiple stakeholders.
  • Strong influencing skills and ability to lead without formal authority.

Educational Background:

  • PhD or equivalent degree in Life Sciences is desirable.

Why Join Novartis?

  • Competitive Salary & Benefits
  • Dynamic and Inclusive Work Environment
  • Cutting-Edge Technologies & Innovation
  • Global Collaboration & Career Growth Opportunities
  • Diverse & Inclusive Culture

Diversity & Inclusion Commitment

Novartis is committed to building a diverse and inclusive work environment that represents the patients and communities we serve.

Accessibility & Accommodations

If you require reasonable accommodations due to a medical condition or disability, please contact inclusion.switzerland@novartis.com, mentioning the job requisition ID (REQ-10030115) in your message.

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