• CRO/CMO Management of API Manufacturing of Small Molecules and Tides (mainly Oligonucleotides)
• Project Management Support, including demand/timeline planning and Legal support (CDA, POs, MSA, others)
• Physio-chemical property assessment and feasibility studies
• Route-finding and process development activities with external partners
• Support of internal project teams in the candidate selection phase
• Supervising solid phase assessments (Polymorph and salt/co-crystal screening), selection of appropriate development form
• Due Diligences of CMC related information for new in-licensing candidates
• Selection and evaluation of suitable GMP CROs
• Supply chain management of APIs, RSMs (Regulatory Starting Materials), and other critical reagents
• Cost of good assessment and support of commercial phase preparation
• Supervising external CROs during the GMP manufacturing phase for clinical study supply and early commercial phases
• Specific experience in impurity profiling and assessment
• Documentation and quality control of all dossier-relevant reports (external and internal ones) including Master Batch records and Analytical Validation Protocols and Reports
• Supervising the preparation of regulatory documents (IMPDs, CTD Module 3 documentation for drug substance, support IP preparation)
• Organizing of GMP audits, selection of auditors, and participating as technical expert in audits
• Management and support of external consultants
• Close interaction with QA/QC and regulatory department to follow up CAPAs, change controls and any other related activities in the drug substance manufacturing process, support of QP release
• Update of all relevant internal SOPs and preparation of new SOPs for further quality improvement
• Support of patent team to generate new IP during development and during commercial phase
• Experience in post-approval activities
• Representation of CMC activities in internal and external project team meetings
• Representation of AiCuris’ CMC team at conferences, exhibitions and CRO/CMO meetings

• PhD (or other adequate title) in Chemistry or other adequate title
• More than 3 years proven experience in her/his area of responsibility with specific focus on process development and GMP manufacturing
• Broad experience in route scouting and proven records in process development with additional experience in green chemistry trends
• State of the art knowledge in industrial process chemistry (modern and scalable synthesis experience)
• Leadership skills leading a team of at least 2-5 people
• Experience in different regulatory areas: EMA, FDA and other authorities
• Regulatory experience with proven record in Quality Control activities
• Experience in CTD Module 3 writing for EMA and FDA submission
• Support of regulatory dossier writers and agencies
• Sound expertise in route finding, process development, GMP manufacturing for clinical study supply and early commercial phase, analytical method development and validation is essential
• Ability to efficiently evaluate, prioritize and handle multiple project tasks
• Experience in managing alliances with international external partners
• Highly motivated, able to work independently and in a team
• Ability to lead larger (project) teams having sole responsibility
• Ability to think strategically about projects and business issues
• Strong analytical and project management 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

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.