Location: Leipzig

Head of Project Group – GMP Process Development / GMP Production

The Fraunhofer-Gesellschaft (www.fraunhofer.com) currently operates 76 institutes and research institutions throughout Germany and is the world's leading applied research organization. Around 30,000 employees work with an annual research budget of 2.9 billion euros.

The Fraunhofer Institute for Cell Therapy and Immunology (IZI) undertakes research and develops specific solutions at the intersection point of medicine, biosciences, and engineering sciences. One of our main activities involves commissioned research for biotechnological, pharmaceutical, and medical engineering companies as well as hospitals, diagnostic laboratories, and research facilities.

The GMP Development Unit / ATMP Design is concerned with the development and optimization of processes and methods in support of the production and quality control of medicines linked to new therapies (tissue engineering products, somatic cell therapy, gene therapy) as well as adeno-associated vectors (AAV). We have a clear vision of the direction in which our GMP Development Unit / ATMP Design needs to develop. Now it is up to you to support the team through this process.

What you will do
You will perform your tasks at the central, interdisciplinary interface of engineering, medicine, and biology. In particular, the position will involve the coordination of activities aimed at the GMP process development and GMP production of biomolecules (especially vectors) within the GMP Development Unit / ATMP Design.

What you bring to the table

• Several years' industrial experience, degree in a scientific discipline (biology, biological engineering, pharmaceutical) or similar field, completed doctorate
• Industrial and academic network (national and international) with proven track record in securing project funding
• Long-standing expertise in the GMP production of vectors
• High level of expertise in the development of vector cell lines, relevant upstream and downstream processes, and filling / finishing processes to the benchmark for clinical studies
• Extensive knowledge of the legal foundations governing the manufacture of vectors (e.g., AMWHV, AMG, GMP guidelines)
• Profound technical and scientific knowledge, strong interest in process establishment/optimisation and GMP processes
• Experience in quality assurance and the compilation of development plans and reports
• Strong command of English at negotiating level
• Experience in managing employees

Your approach to work will be autonomous, structured, and dependable in the extreme. If you are also highly motivated with outstanding organisational skills, assertiveness, and the ability to keep on top of things – even under time pressure – we look forward to hearing from you. As you take leadership of an ambitious production team in the vector field, you will assume responsibility for smooth processes, project acquisition, scientific and technological prominence and internal and external networking for yourself and your team.

What you can expect

• Vocational and personal development opportunities that will allow you to indulge your interests and explore new subject areas
• Good work-life balance with flexible working hours
• Help with reconciling family and professional life
• Wide-ranging sporting options and healthcare services
• Personal development through the acquisition of new qualifications

We value and promote the diversity of our employees' skills and therefore welcome all applications - regardless of age, gender, nationality, ethnic and social origin, religion, ideology, disability, sexual orientation and identity. In case of identical qualifications preference will be given to severely disabled candidates.

The weekly working time is 39 hours. Appointment, remuneration and social security benefits based on the public-sector collective wage agreement (TVöD). Additionally, Fraunhofer may grant performance-based variable remuneration components.

With its focus on developing key technologies that are vital for the future and enabling the commercial utilization of this work by business and industry, Fraunhofer plays a central role in the innovation process. As a pioneer and catalyst for groundbreaking developments and scientific excellence, Fraunhofer helps shape society now and in the future.

Interested? Apply online now. We look forward to getting to know you!

If you have any specific questions on the position, please do not hesitate to contact:

Mr. Dr. Stephan Fricke
Phone: +49 341 35536-2205 or -2242

Fraunhofer-Institut für Zelltherapie und Immunologie IZI
www.izi.fraunhofer.de

Requisition Number: 24934