Clinical Supply Manager (m/f/x)

Our mission

At Ethris, we are working at the forefront of medical innovation and technology. To us, this is a once-in-a-lifetime chance, working on rethinking human therapeutics. We strive towards developing the next generation of mRNA therapeutics and vaccines for respiratory diseases. We're a dedicated and skilled team of around 70 with different cultural backgrounds, all following the goal of revolutionizing medicine and bringing ground-breaking new therapies to patients worldwide. With our truly innovative, self-developed and IP-protected suite of platforms for lipidoid nanoparticle delivery, mRNA design and optimization, mRNA manufacturing and drug product stabilization at room-temperature, we are uniquely positioned to achieve our ambitious goals.

OUR OFFER

As a highly ambitious and thriving biotech company, we offer you an extremely interesting but also demanding job. You will have the opportunity to quickly expand your operational, strategic, and personal skills in a highly motivated team. An open communication culture and working atmosphere combined with a strong team spirit contribute to our success.

Join our team as Clinical Supply Manager (m/f/x), advance your career, and become part of an amazing journey to bring new and breakthrough genetic medicine to patients worldwide.

Your tasks

• Assessing project needs for the supply chain from GMP manufacturing (raw- and starting materials, consumables) to clinical trial supply (IMP, non-IMPs, devices and ancillaries)
• Evaluating and setting up material- and trial supply schemes involving vendors, CMOs distribution depots and investigative sites
• Supervising, coordinating and executing clinical supply procurement, storage, distribution, release and return/destruction activities
• Creating clinical supply budgets/timelines and participating in vendor selection
• Developing and verifying project-specific packaging specifications and label design
• Elaborating clinical supply plans, providing input for the development of vendor management plans and RTSM systems
• Generation and/or review of regulatory documents and ensuring all clinical supply documentation is distributed to relevant parties and is filed in the eTMF
• Supporting teams in clinical product management and liaising with internal project teams, company divisions and vendors
• Be part of the interdisciplinary team developing the quality strategy for Ethris products for early phases to market supply and grant information flow regarding production requirements

Your profile

• Ideally educational background in chemistry, biochemistry, pharmaceutics, or a related discipline
• Experience in CMC and/or clinical supply management
• In-depth knowledge of GMP, GDP and relevant regulations, basic knowledge on GCP requirements
• You are open-minded and creative and enjoy developing new concepts and strategies
• Strong team player; excellent communication and presentation skills for interaction with both external and internal stakeholders
• Organizational and structured work method while remaining adaptable to evolving project dynamics and changing requirements
• Good command of written and spoken English

Zuletzt aktualisiert am 19.04.2024