Project Manager Analytical Development (m/w/d)

Job Purpose

The Analytical Development Project Manager is responsible for leading all analytical activities for assigned drug substances (DS) and drug products (DP). This role covers the entire lifecycle from early-stage clinical development through to technical transfer and commercialization with focus on small molecules.

Key Responsibilities

• Analytical Leadership: Serve as the primary analytical expert and representative in cross-functional CMC project teams.
• External Management (CRO/CMO): Manage and oversee analytical activities at external contract research and manufacturing organizations, including method development, validation, and routine testing.
• Strategy & Planning: Define the analytical development strategy, including stability study designs and specification settings in compliance with ICH guidelines.
• Regulatory Documentation: Author and review high-quality CMC sections for regulatory filings (e.g., IND, IMPD, NDA, MAA) and address inquiries from health authorities (EMA, FDA, etc.).
• Quality Compliance: Ensure all analytical activities are performed in strict accordance with cGMP standards and internal Quality Management Systems.
• Troubleshooting: Lead investigations into Out-of-Specification (OOS) results or technical challenges during method transfer and stability testing.

Required Qualifications & Skills

• Ph.D. or Master’s degree in Chemistry, Pharmacy, or a related life science field.
• Experience: At least 5+ years of professional experience in the pharmaceutical industry, specifically as a project manager in analytical development or QC under a GMP environment.
• Strong background in chromatography (HPLC/UPLC, GC) and other state-of-the-art analytical techniques for small molecules or biologics.
• Deep understanding of ICH, FDA, and EMA guidelines regarding stability, validation and impurities.
• Excellent project management skills with the ability to manage multiple priorities.
• Strong negotiation skills for handling external vendors are of advantage.
• Fluency in English (written and spoken) is mandatory, German is an asset.