Analytical Project Lead (Synthetic Molecules)

Lead Cutting-Edge Analytical Development Projects

Join a dynamic team in Switzerland to drive the development of innovative therapies from the laboratory to patients worldwide. In this role, you will focus on analytical development for synthetic molecules, utilizing advanced techniques such as high-performance liquid chromatography (HPLC), gas-ion chromatography, and mass spectrometry. You will play a pivotal role in ensuring the release of clinical trial products and their eventual commercial supply through robust control strategies.

To be considered for this role, you must have the right to work in this location or hold an EU passport.

Responsibilities

• Serve as the Analytical Subject Matter Expert (SME) and project lead, driving the development of analytical control packages for synthetic molecules, including direct materials, intermediates, and crude APIs.
• Ensure efficient and effective process development analytics, adopting modern techniques like modeling and simulation.
• Coach technicians and junior scientists, providing guidance on project work and serving as a central point of contact for project-related information.
• Supervise internal laboratory activities and testing activities at Contract Laboratory Organizations (CLOs) or Contract Development and Manufacturing Organizations (CDMOs).
• Collaborate cross-functionally with research, early development, regulatory, and quality teams 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), overseeing external testing activities at CDMOs or CLOs.

Key Skills and Requirements

• Advanced degree (Master's or PhD) in chemistry, pharmacy, or a related field.
• Strong foundation in analytical development, particularly for synthetic peptides.
• Proficiency in liquid chromatography techniques (HPLC, UHPLC) and various detection methods, including UV, Mass Spectrometry (MS), fluorescence, and charged aerosol detection.
• Solid understanding of analytical chemistry, including chromatographic techniques, titrations, and physicochemical methods.
• Excellent collaboration, technical supervision, and project management skills with a structured and rigorous approach.
• Digital acumen to support digital transformation initiatives and familiarity with statistical analysis of analytical data.
• Fluency in English (written and spoken).

Nice to Haves

• Proficiency in German is considered a plus.