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Analytical Project Leader

Posted 1 hour 5 minutes ago by Elan Personal AG

Permanent
Not Specified
Laboratory Jobs
Not Specified, Switzerland
Job Description
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
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 Afonso.
Basel-Stadt Aargau Pharma Science Senior Scientist Project Leader Chemistry HPLC UPLC GMP jid59a915aa jit0520a jiy26a
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