Your mission
As a Drug Product Manager* you will be part of our CMC management drug product team supporting all clinical projects with respect to product quality, CMO management, and CMC documentation for regulatory dossiers.
Responsibilities
* Coordination of pre-formulation and compatibility studies within the formulation development
* Project management of pharmaceutical development and manufacturing of Drug Product for clinical projects (Phases I to III)
* Cross-functional coordination of tasks with involved project team members
* Selection of and collaboration of external service providers and consultants
* Development and optimization of galenic forms and compositions, in particular solid and i.v. formulations
* Monitoring of project timelines, deliverables and costs for Drug Product
* Contribution to CMC part for compilation of submission documents to regulatory agencies e.g. IMPD, IND up to NDA and supporting and participating in regulatory meetings with FDA and national authorities in Europe
* Work with development team to give advice concerning quality aspects and clinical supplies handling
* Support our QA/QC team handling deviations and CAPAs
Your profile
* PhD (or other adequate title) in Chemistry or Pharmaceutical technology or other adequate title
* > 3 years of professional experience in pharmaceutical / Biotech industry
* Expertise in galenic development for solid and liquid forms including i.v. formulations
* Advanced knowledge of Drug Development process, analytical development and validation as well as GMP/CMC and regulatory requirements
* Ability to efficiently evaluate, prioritize and handle multiple project tasks
* Ability to lead larger (project) teams having sole responsibility
* Experience in managing alliances with external international partners
* Highly motivated and ability to work in team in house as well as with CROs, experts and opinion leaders
* Good organizational, management and communication skills, capable of setting priorities and to manage high workload
* Ability to think strategically about projects and business issues
* Strong analytical and project management skills
* Positive & constructive attitude, people management competencies and trustworthy
* 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 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
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