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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 (80-100%)

Location: Basel, Switzerland
Employment Type: Full-time
Job Requisition ID: REQ-10030115


Role Purpose:

The Senior Method Expert in Analytical Sciences plays a critical role in developing and optimizing physicochemical analytical (PCA) methods for biopharmaceutical molecules. This role involves method development using Quality-by-Design (QbD) principles, automation and miniaturization, data-driven analytics, and ensuring regulatory compliance for drug substance and drug product development. Additionally, the expert provides technical leadership, mentorship, and collaboration across cross-functional teams.


Key Responsibilities:

Method Development & Optimization:

  • Develop and optimize physicochemical analytical (PCA) methods using Quality-by-Design (QbD) principles.
  • Design experiments, perform risk assessments, and apply statistical tools to establish robust analytical methods.
  • Ensure method performance trending by implementing trend/control charts for relevant parameters.

Advanced Instrumentation & Automation:

  • Utilize state-of-the-art analytical instrumentation such as HPLC/UPLC, CE, cIEF for method development.
  • Implement automation and miniaturization strategies to increase throughput and reduce reagent consumption.
  • Apply machine learning, data analytics, and modeling to optimize analytical method performance.

Regulatory Compliance & Documentation:

  • Ensure compliance with ICH Q2(R2), ICH Q14, and other evolving regulatory guidelines.
  • Support regulatory filings and validation strategies.
  • Stay updated on regulatory expectations and incorporate them into method development processes.

Collaboration & Leadership:

  • Work closely with cross-functional teams, including research, drug substance (DS) & drug product (DP) process development, quality assurance, and regulatory affairs.
  • Provide technical leadership, mentorship, and guidance to junior team members.
  • Influence and drive projects within a matrix environment.

Required Qualifications & Experience:

Technical Expertise:

  • Strong hands-on experience in analytical instrumentation (HPLC/UPLC, CE, cIEF).
  • Senior expertise in physicochemical analytical method development and Quality-by-Design (QbD) principles.
  • Proficiency in automation, digital tools, and data-driven analytics.
  • Deep scientific knowledge in pharmaceutical development and analytical sciences.
  • Experience in biotechnological CMC development.

Educational & Professional Background:

  • PhD or equivalent degree in life sciences (preferred).
  • Minimum 10 years of proven industry experience in pharmaceutical or biopharmaceutical analytical sciences.

Key Competencies:

  • Ability to work effectively in a matrix environment.
  • Strong influencing and leadership skills without direct authority.
  • Effective communication and collaboration across global teams.

Why Join Us?

  • Be part of a high-impact team driving innovation in biologics drug development.
  • Work in a dynamic and collaborative environment in Basel, Switzerland, a vibrant European region rich in culture and outdoor activities.
  • Competitive compensation & benefits with opportunities for career growth.
  • Contribute to life-changing medicines and improve patient outcomes globally.

How to Apply:

Interested candidates can apply through Novartis' official career portal.

Join us in shaping the future of biopharmaceutical analytics and advancing scientific excellence! 🚀