Drug Product Manager Reporting to the Vice President CMC IP

• CMO/ CDMO/ CRO management for pharmaceutical development and drug product manufacturing for clinical study supply and early commercial phases
• Management of all aspects of technical drug product development (eg analytics galenic forms and compositions in particular: solid and i.v. formulations)
• Coordination of preformulation and compatibility studies within the formulation development
• Collaboration with clinical development teams to give advice on quality aspects and clinical supplies handling
• 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 postapproval 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)
• Close interaction with QA/QC to manage CAPAs change controls quality incidents and participating in audits as technical expert

• PhD (or equivalent) in Chemistry or Pharmaceutical Technology or similar
• At least 5 years of professional experience in the pharmaceutical / biotech industry
• Profound experience in CMC development for early and latephase programs specifically with drug product 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 GMPcompliant drug product 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: Employerfunded pension comes along with an attractive benefits package

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.