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

Festanstellung, Vollzeit · Hybrid

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

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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.

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