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

at  AiCuris Antiinfective Cures AG

YOUR MISSION

As a Drug Substance Manager* you will be responsible for the co-ordination of all GMP-related internal and external Drug Substance-activities for all the AiCuris small molecule research and development projects.

Responsibilities

• 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

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.

• 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 meeting