Analytical Project Leader (Scientist / Senior Scientist)

Roche Switzerland bridges the gap between pharmaceuticals and diagnostics. Important research and development functions are located here. For our long-term client, F. Hoffmann-La Roche AG in Basel, we are looking for a

Background:

The Analytical Research & Development department is a key part of Synthetic Molecules Technical Development. It is globally responsible for advancing analytical methodologies, performing in-depth analyses of active pharmaceutical ingredients, and diverse dosage forms, as well as preparing detailed regulatory documentation for submission to health authorities.
In this role, you will join a motivated and experienced team of analytical scientists. You will lead the analytical development of synthetic molecule projects involving small molecules, from early development to commercialization. This role offers a unique opportunity to apply your expertise in a dynamic, fast-paced environment and contribute to the development of life-changing medicines.

Tasks & 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

Must Haves:

• 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
• In-depth knowledge of chemistry, including synthesis, purification, and characterization
• 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 Have:

• Proficiency in German

What you will be offered:

• An opportunity to work in one of the world's most important pharmaceutical companies
• Modern campus with plenty of green spaces and meeting areas
• Central location in Basel
• Varied job profile
• Further training opportunities through temptraining
• Working in a dynamic and motivated team

If you are interested please send your application documents addressed to Ms Diana Afonso.

Basel-Stadt Aargau Pharma Science Senior Scientist Project Leader Chemistry HPLC UPLC GMP

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