Analytical Project Leader (Scientist / Senior Scientist)
Elan Personal AGVous cherchez un emploi de Analytical Project Leader (Scientist / Senior Scientist) a Basel ? Elan Personal AG recrute.
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
Analytical Project Leader (Scientist / Senior Scientist)
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 Ph.D. 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
Ce poste est a pourvoir rapidement. Candidatez sans tarder.
