Analytical Expert

Vor 2 Tagen

Basel, Schweiz Novartis Farmacéutica Vollzeit
Analytical Expert (Science & Operations) - Senior Expert

Job ID REQ-10035452

Jan 09, 2025

Summary

Location: Basel, Switzerland

Role Purpose:
We are looking for a highly motivated Analytical Expert to support Analytical Research & Development (ARD). ARD sits within the Global Technical R&D department of Development and plays an essential role in the characterization and analysis of Small Molecule Drug Substances and Drug Products from the time they leave the discovery laboratory until they are transferred to Commercial Production. The role will be part of the Small Molecules GMP Analytics Team with focus on small molecules and Radioligand Therapy. The candidate should have a strong background and experience in GC, HPLC and cGMP analytics.

About the Role

Main responsibilities:

  • Plan, interpret and report results of scientific experiments for DS and/or DP applying state of the art analytical science and technologies (e.g., analytical method validations/transfers/stability/release testing, cleaning verification etc.) according to the agreed timelines. Ensure compliance to cGMP.
  • Execute and evaluate experiments in the laboratory as required
  • Write and review analytical documents (raw data review/approval, batch records review, validation protocol, SOPs, .....)
  • Provide scientific guidance to laboratory associates
  • Manage Out-Of-Specification results and Analytical Deviations and propose adequate CAPAs
  • Ensure implementation of new technologies and smooth handover of analytical methods in collaboration with ARD Analytical Development team
  • Lead and manage assigned non-drug projects/local network activities and contribute to strategic decisions
  • Manage interactions and contribute to a high level of collaboration with internal and external stakeholders
  • Support audits and health authority inspections and ensure no critical findings within the assigned scope
  • Exhibit strong team spirit and promote knowledge exchange
  • Develop, coach and mentor laboratory scientists and other associates

What you'll bring:

  • PhD or Master degree in analytical chemistry or equivalent and a minimum of 5 year's experience in the pharmaceutical industry
  • Strong expertise in Gaz Chromatography, including method development and method validation
  • Strong expertise in other analytical techniques, e.g. HPLC, cleaning verification, X-Ray, IR, etc..
  • GMP experience
  • Experience in LC-MS is a plus
  • Strong coordination and communication skills, collaborative spirit, self-driven attitude, high level of learning agility are key attitudes

Languages :

  • German as a plus

Commitment to Diversity and Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

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