Analytical Project Leader (Scientist / Senior Scientist)
(m/f/d)
Freelance/temporary employment for a project Basel Stadt Start date: asap Reference number: 873611/1
Diesen Job teilen oder drucken
Responsibilities
1. Developing a phase-appropriate control strategy for drug substances and drug products
2. Collaborating effectively with stakeholders across various departments
3. 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
4. Coaching technicians and junior scientists on project work and serving as a central point of contact for project-related information
5. Conduct work in compliance with cGMP where applicable, safety, and regulatory requirements
6. Supervise internal laboratory activities and / or testing activities at CLOs/CDMOs
7. Plan and document experiments/results independently and prepare for regulatory submissions such as IND and NDA
Profile
8. 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
9. Expertise in key analytical techniques such as High-Performance Liquid Chromatography (HPLC), Ultra-Performance Liquid Chromatography (UPLC)
10. Proven experience in developing and validating ICH-compliant analytical methods
11. Proficiency in degradation and stability studies for small molecules, including forced degradation and impurity profiling
12. Understanding of key requirements for drug substances and drug product specifications
13. Excellent command of the English language
14. 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
15. 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
16. Nice to Haves: Proficiency in German
Benefits
17. A very renowned company
18. You will work in an international environment