Your mission
As a Drug Product Manager
* Support all development projects related to clinical and commercial drug supply, ensuring product quality, managing CMOs / CDMOs / CROs, and preparing CMC documentation for regulatory dossiers.
Responsibilities
* Manage CMO / CDMO / CRO relationships for pharmaceutical development and drug product manufacturing for clinical and early commercial phases.
* Oversee technical drug product development, including analytics, galenic forms, and formulations (solid and i.v.).
* Coordinate with QA / QC to manage CAPAs, change controls, quality incidents, SOP writing, and audits as a technical expert.
* Lead pre-formulation and compatibility studies within formulation development.
* Collaborate with clinical teams on quality aspects and clinical supplies handling.
* Support the selection and evaluation of CMOs / CDMOs / CROs for GMP manufacturing and testing.
* Assist in regulatory filings in the US and EU (e.g., CTD module 3) and review relevant quality documentation.
Your profile
* PhD (or equivalent) in Chemistry, Pharmaceutical Technology, or related field.
* Minimum of 5 years post-graduate experience in the pharmaceutical/biotech industry.
* Extensive experience in CMC development for various phases, focusing on drug product activities.
* Knowledge of QbD and DoE principles.
* Experience managing external partners like CMO / CDMO / CRO.
* Experience supporting US and EU regulatory filings.
* Strong GMP expertise in drug manufacturing and testing, including validation and transfer.
* Ability to manage multiple projects efficiently.
* Motivated, independent, and team-oriented.
* Excellent organizational and communication skills.
* Fluent in English; German skills are a plus.
Why us?
* Unique culture emphasizing scientific excellence, collaboration, and patient impact.
* Opportunities for personal growth and development.
* Flexible working arrangements.
* Attractive benefits, including employer-funded pension.
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