Analytical Expert

vor 1 Tag

Basel, Basel-Stadt, Schweiz Actalent Vollzeit

For one of our clients based in Basel, we are seeking an
Analytical Expert
, with a strong experience in parenteral development and in technical development.

Key Responsibilities

  • Plan, interpret and report results of scientific experiments for timely supply of drug substances (DS) and drug products (DP).
  • Write & review analytical documents (e.g Analytical methods, Specifications, Validation reports, Stability reports, Batch records for stability and release testing) and align the corresponding activities within a global project team.
  • Drive method development for peptide drug substances and RLT Drug product
  • Manage interactions with internal and external stakeholders, including outsourced activities to CROs by providing scientific and technical guidance whenever necessary.
  • Proactively identify scientific, technological and GMP challenges, propose creative solutions and communicate key issues to the Analytical Project Leader or respective technical project team.
  • Work according to appropriate SOPs, GMP, Quality Directives, Health and Safety & internal Novartis guidelines.
  • Provide valuable input to the analytical CMC documents and support regulatory submissions.
  • Drive, lead, and manage analytical activities including impurity profiling related to the analytical development of RLTs compounds (e. g. method development, validation, stability, and release testing)
  • Provide scientific guidance to the cross-functional and global project teams and thereby scientifically driving our exciting RLT portfolio.
  • Good understanding and awareness of regulatory guidelines for analytical development

Qualifications

  • PhD in analytical chemistry or equivalent
  • At least 5 years experience in the pharmaceutical industry with a track record in GMP activities for development or marketed products.
  • Profound expertise in documentation writing (Stability Report, Validation, IND IMPD modules etc)
  • Broad scientific knowledge in chemistry, pharmaceutical or analytical sciences, ability to perform in a highly dynamic environment
  • Advanced knowledge of laboratory and/or technical tools (e.g. HPLC, LC-MS, Quality management systems, statistical evaluation tools ...)
  • Fluent in English (oral and writing)

Job Type:
1 year contract

Start Date
: 01/12/2025

On site required

Work Location:
Basel

Workload:
100%

*While we appreciate every application, please note that due to the high volume of responses, we may only be able to contact shortlisted candidates.

**Please note that we can only consider EU/Schengen applications

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