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
Technical R&D - Analytical Project Lead
Background:
Pharma Technical Development (PTD) is a global team of over 2,000 experts focused on developing innovative medicines to address patients' needs.
Within PTD, Synthetic Molecules Technical Development (PTDC) specializes in drug substance, drug product, and analytical sciences. PTDC is instrumental in advancing the synthetic molecules pipeline, supporting research, early development, and clinical trials through technical innovation and collaboration.
This opportunity lies within analytical development for synthetic molecules, where cutting-edge techniques like high-performance liquid chromatography, gas/ion chromatography, and mass spectrometry are employed to develop efficient and robust analytical methods. The goal is to ensure the release of clinical trial products and their eventual commercial supply through a strong control strategy.
Tasks & Responsibilities:
- Serve as the Analytical SME/analytical project lead (APL), driving the development of state-of-the-art analytical control packages for synthetic molecules, including direct materials, IPCs, intermediates, and crude APIs
- Actively contribute to portfolio delivery by ensuring efficient and effective process development analytics, including the adoption of modern techniques like modeling and simulation
- Coaching technicians and junior scientists on project work and serving as a central point of contact for project-related information
- Supervise internal laboratory activities and / or testing activities at CLOs/CDMOs
- Collaborate cross-functionally with key partners in research and early development, Regulatory, and Quality to ensure seamless project execution and alignment
- Author, review, and approve critical documents and regulatory dossiers (e.g., QIMPD, NDA) while ensuring compliance with quality standards and data integrity
- Act as a Chemistry Project Lead (CPL), leading external testing activities at CDMOs or CLOs, and contributing to the hiring and coaching of new colleagues
Must Haves:
- A Master's or Ph.D. in chemistry, pharmacy, or a related field
- Min. 5 years of professional experience within the analytical development of synthetic molecules drug substances
- A robust foundation in liquid chromatography (HPLC and UHPLC) with proficiency in various detection methods, including UV, Mass Spectrometry (MS), fluorescence, and charged aerosol detection
- You possess a solid understanding of analytical chemistry, particularly chromatographic techniques (HPLC, GC), titrations, and various physicochemical methods
- You demonstrate excellent collaboration, technical supervision, and project management skills, with a structured and rigorous approach
- Digital acumen to support digital transformation initiatives; familiarity with statistical analysis of analytical data is also advantageous
- Excellent command of the English language
Nice to Have:
- Proficiency in German is considered a plus
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 R&D Project Lead SME APL IPC API CPL CDMO CLO