Analytical Project Leader – ADA

Overview

Our client is a leading Swiss multinational healthcare company headquartered in Basel, Switzerland. Operating in Pharmaceuticals and Diagnostics, it is one of the world’s largest biotech companies and a global leader in in-vitro diagnostics and cancer treatments.

In this role you will be joining a highly motivated and experienced team of analytical scientists. You will be responsible for leading analytical development activities for synthetic molecule projects
, from early development to commercialization
. This is an exciting opportunity to apply your expertise in a dynamic and challenging environment, contributing to the development of life-changing medicines.

The perfect candidate holds a Master's or Ph.D. in chemistry
or pharmacy
, coupled with a minimum of three years of experience within the pharmaceutical industry as an analytical project lead. A robust background in analytical development is paramount, with particular expertise in liquid chromatography and diverse detection methodologies. Beyond technical proficiency, the person is an open-minded, goal-oriented individual who demonstrates the ability to thrive within a dynamic environment. The perfect candidate perceives challenges as opportunities for growth and consistently exhibits respectful collaboration with team members, customers, and stakeholders.

This is a 1-year contract role with possible extension, based in Basel
.

• Developing a phase-appropriate control strategy for drug substances and drug products.
• Collaborating effectively with stakeholders across various departments.
• Coordinating comprehensive analytical activities, which involves generating physical and chemical data for materials, developing/improving and validating analytical test methods or other analytical controls and ensuring thorough documentation, timely delivery and adherence to quality standards.
• Coaching technicians and junior scientists on project work and serving as a central point of contact for project-related information.
• Conduct work in compliance with cGMP where applicable, safety, and regulatory requirements.
• Supervise internal laboratory activities and / or testing activities at CLOs/CDMOs.
• Plan and document experiments/results independently and prepare for regulatory submissions such as IND and NDA.

• Relevant Swiss working/residency permit or Swiss/EU-Citizenship required
• A Master’s or Ph.D. in chemistry, pharmacy, or a related field.
• At least 3 years of professional experience (industry-based) in analytical development of drug substances and products for peptides
  .
• In-depth knowledge of peptide chemistry, including synthesis, purification, and characterization.
• Expertise in key analytical techniques such as High-Performance Liquid Chromatography (HPLC), Ultra-Performance Liquid Chromatography (UPLC) and Mass Spectrometry (MS) for peptide analysis
  .
• Understanding of key requirements for peptide
  drug substances and/or drug product specifications.
• Proven experience in developing and validating ICH-compliant analytical methods
  .
• Proficiency in degradation and stability studies for peptide
  , including forced degradation and impurity profiling.
• Strong knowledge of peptide degradation pathways.
• Digital savviness to support digital transformation initiatives; familiarity with statistical analysis of analytical data is also advantageous.
• Open-minded, goal-oriented, and able to work in a fast-developing environment.
• Takes challenges as opportunities and is able to respectfully collaborate with team members, customers and stakeholders, even in stressful situations.
• Additional experience in analytical development with oligonucleotides or biologically derived molecules is a plus.
• Extended skills for liquid formulations are considered as a plus:
• Understanding of the physicochemical properties of peptides and how they impact formulation development.
• Skilled in conducting systematic stability studies for peptides in liquid formulations under various conditions.
• Excellent command of the English language.