Drug Substance Manager* (Reporting to the Vice President CMC & IP)

Your mission

As a Drug Substance Manager, you will be part of our CMC management team supporting all development projects with respect to managing clinical and commercial drug supply, ensuring product quality, managing CMOs/ CDMOs/ CROs, and preparing CMC documentation for regulatory dossiers.

Responsibilities:

• CMO/ CDMO/ CRO management for API manufacturing of small molecules and Tides (mainly Oligonucleotides) for clinical study supply and early commercial phases.
• Management of all aspects of technical drug substance development (e.g., analytics, solid state assessment, impurity profiling, route finding).
• Supply chain management of APIs, Regulatory Starting Materials, and other critical reagents.
• CMC project management, including clinical supply demand and timeline planning, and representation of CMC in project teams.
• Selection and evaluation of suitable CMOs/ CDMOs/ CROs for GMP manufacture and testing.
• Cost of good assessment, support of commercial phase preparation, and post-approval activities.
• Support of regulatory filings in US and EU (e.g., CTD module 3) and review of quality documentation relevant for manufacturing and testing (e.g., MBR, validation protocols).
• Close interaction with QA/QC to manage CAPAs, change controls, quality incidents, and participating in audits as a technical expert.

Your profile

• PhD (or equivalent) in Chemistry, Pharmaceutical Technology, or similar.
• At least 5 years of professional experience in the pharmaceutical/biotech industry.
• Profound experience in CMC development for early- and late-phase programs, specifically with drug substance related activities.
• Experience in CMO/CDMO/CRO management and collaboration with external partners.
• Experience with supporting regulatory filings in US and EU.
• Sound expertise in GMP-compliant drug substance manufacturing and testing, including validation and transfer.
• Ability to efficiently evaluate, prioritize, and handle multiple project tasks.
• Highly motivated and ability to work independently as well as in a team.
• Excellent organizational and communication skills.
• Business fluent in English; German skills would be beneficial.

Why us?

• Unique corporate culture: Scientific excellence, a collaborative working environment, and the passion to improve the lives of patients define our work. With us, you can work together with innovation-awarded experts with the proven ability to translate science into commercial success. You can expect diversity, inspiration, as well as trustful collaboration.
• Development: We encourage people to grow and strongly support individual development and learning opportunities.
• Flexibility: Embracing flexible working accommodations, we enable our people to integrate business into their personal life.
• Benefits: Employer-funded pension comes along with an attractive benefits package.