Job Overview
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. This role is part of Pharma Technical Development (PTD), a global team of over 2,000 experts focused on developing innovative medicines. Within PTD, Synthetic Molecules Technical Development (PTDC) specializes in drug substance, drug product, and analytical sciences. The Analytical Project Lead will develop state‑of‑the‑art analytical control packages for synthetic molecules, ensuring release of clinical‑trial products and eventual commercial supply.
Key Responsibilities
Serve as the Analytical SME/analytical project lead (APL), driving the development of 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 such as modeling and simulation.
Coach technicians and junior scientists on project work and act as the 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.
Minimum 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.
Solid understanding of analytical chemistry, particularly chromatographic techniques (HPLC, GC), titrations, and various physicochemical methods.
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.
Benefits
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 temporary training.
Working in a dynamic and motivated team.
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