Welcome Back

Google icon Sign in with Google
OR
I agree to abide by Pharmadaily Terms of Service and its Privacy Policy

Create Account

Google icon Sign up with Google
OR
By signing up, you agree to our Terms of Service and Privacy Policy
Instagram
youtube
Facebook

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

Syngene
Syngene
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! 🚀