Chemist (m/w/d)

AiCuris GmbH & Co. KG

42117 Wuppertal - Deutschland

Chemiker/in Arbeit Vollzeit ab 24.09.2025

Beschreibung

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.

Drug Substance Manager*
Permanent employee, Full-time · Wuppertal | GER | HQ
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 (eg, analytics, solid state assessment, impurity profiling, route finding)
Close interaction with QA/QC to manage CAPAs, change controls, quality incidents, writing of SOPs and participating in audits as technical expert
Supply chain management of APIs, Regulatory Starting Materials, and other critical reagents
Support of 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 fillings in US and EU (eg, CTD module 3) and review of quality documentation relevant for manufacturing and testing (eg, MBR, validation protocols)

PhD (or equivalent) in Chemistry or Pharmaceutical Technology or similar
At least 5 years of post-graduate professional experience in the pharmaceutical / biotech industry
Profound experience in CMC development for early- and late-phase programs, specifically with drug substance related activities
Exposure to the principles of QbD (Quality by Design) and DoE (Design of Experiment)
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 the team
Excellent organizational and communication skills
Business fluent in English; German skills would be beneficial

Unique corporate culture: Scientific excellence, a collaborative working environment and the passion to improve the lives of patients defines 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

Quelle: Bundesagentur für Arbeit - Rechtliche Hinweise zur Nutzung
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