Analytical Project Leader (Scientist / Senior Scientist) (m/f/d)

Analytical Project Leader (Scientist / Senior Scientist)

(m/f/d)

Freelance/Contracting project Basel Stadt Start date: asap Reference number: 873611/1

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Responsibilities

• 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

Profile

• A Master’s or in chemistry, pharmacy, or a related field, with at least three years of professional experience in analytical development of drug substances or drug products for small molecules
• Expertise in key analytical techniques such as High-Performance Liquid Chromatography (HPLC), Ultra-Performance Liquid Chromatography (UPLC)
• Proven experience in developing and validating ICH-compliant analytical methods
• Proficiency in degradation and stability studies for small molecules, including forced degradation and impurity profiling
• Understanding of key requirements for drug substances and drug product specifications
• Excellent command of the English language
• A strong quality mindset and excellent attention to detail. 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
• Nice to Haves: Proficiency in German

Benefits

• A very renowned company
• You will work in an international environment