Director CMC* (Reporting to Vice President CMC & IP)

Your mission

At AiCuris, the role of Director CMC* is to lead the chemistry, manufacturing and control activities. With Pritelivir we have a product candidate close to market approval and several earlier stage drugs. We are looking for an expert with the ability to orchestrate chemistry, analytical chemistry, formulations, our internal team of experts and various CDMOs integrated into the pharmaceutical development of our product candidates from preclinical stage to commercial. Key focus of your work will be the new pharmaceutical product application and preparation of commercial drug supply of our proprietary lead product candidate.
Responsibilities:

• Manage Chemistry, Manufacture and Analytical Control of the entire development products from early phase I up to submission for market authorization.
• Lead the CMC aspects of product development programs and manage the Pharmaceutical Development group. Provide scientific and technical expertise into selection of new drug candidates and development programs.
• Validation and registration batch generation for drug substance and drug product 
• Process validation and qualification of analytics for Phase 3 product candidate
• Setup of a commercial supply chain and related agreements
• Manage multiple vendors and CDMOs as well as qualification/auditing of CDMO
• Responsible for CMC sections of regulatory filings documents (e.g. IMPD, IND, NDA) to national authorities including FDA and BfarM 
• Ensure that sound technical data sufficient for regulatory filings is collected and appropriately reviewed. 
• Ensure that Pharmaceutical Development activities are conducted in compliance with applicable GMP/GLP and QSR requirements.
• Develop and budget resource forecasts
• Ensure compliance with quality standards in the CMC laboratory
• Provides guidance, mentoring, and development of staff; ensures the team has appropriate skills, capabilities, and resources to meet current and future business needs
• Identify and develop formulation technologies applicable to potential product candidates
• Oversee QA/QC topics relevant for CMC aspects (deviation and CAPA management), support of audits and external service provider qualification

Your profile

• PhD degree in chemistry, biochemistry, pharmaceutical science, chemical engineering or equivalent
• At least 10-12 years’ proven experience in pharmaceutical technical development disciplines in the pharmaceutical industry with strong background in chemistry, analytics, drug development
• Experience in managing API synthesis and pharmaceutical development activities in early phases as well as in a GMP environment and in preparing the CMC part of IMPD / IND
• Working understanding of GMP regulations and guidance applicable to the development of products
• Proven track record of successful product development with experience and knowledge across a broad range of different pharmaceutical technologies
• Understanding of international GMP regulations and guidance applicable to the development of products
• Experience with EMA and possibly FDA and understanding of regulatory requirements.
• Experienced in complex project management, negotiations with external partners and Due Diligence processes
• Audit experience
• Capacity of effectively organizing and monitoring projects and plans with attention to detail and deadlines to secure progress and goal achievement
• Persuasive pro-active manager and trustful, reliable person with entrepreneurial spirit, who generates enthusiasm and positive group dynamics
• Excellent team-oriented leadership and management skills
• Ability to contribute and work in a growing and changing organization

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