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

at  AiCuris Antiinfective Cures AG

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

ABOUT US

AiCuris is meeting the needs of the growing population of immunocompromised people who require precise therapies to effectively treat infection. Our flagship product, PREVYMIS, marketed by our partner MSD, treats CMV in a defined group of transplant recipients. Our pivotal phase 3 candidate Pritelivir aims to address recurrent and resistant HSV infections in a broad population of patients with weakened immune systems. For immunocompromised people, an otherwise manageable infection can mean life or death. AiCuris, with its expertise and growing pipeline, is committed to providing therapeutic solutions for them now and in the future.

Passionate about our mission to develop anti-infective therapeutics for patients in need, a team of internationally recognized experts is driving our research and development to improve the lives of patients. We believe in a culture of trust and transparency, where feedback is considered an opportunity to contribute to each other’s personal and professional growth. We hire people who are collaborative, adaptable, communicate well, and love to learn.

• AiCuris is an employer that supports equal opportunities, diversity and inclusion. We welcome applications from people regardless of their national origin, skin color, religion, gender, age, marital status, disability, sexual orientation, gender identity or other legally protected characteristics.

• 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 CAPA