Company Description
For 35 years, we have been developing cutting-edge science and technology to empower biomedical research and personalized medicine. We combine excellence from more than 60 disciplines in natural sciences, engineering, and informatics to significantly contribute to biomedical sciences. We encourage a creative working environment driven by pioneering spirit – to seek new horizons – boldly envisioning the future and turning it into reality. Today, more than 4,700 experts from over 50 countries contribute to our sustainable success.
Job Description
Miltenyi Biotec is at the forefront of developing innovative, cell-based therapies for cancer, autoimmune diseases, and rare conditions. We are seeking an Analytical Project Lead to play a pivotal role in translating cutting-edge science into practical medical solutions.
The successful candidate will be responsible for the following critical functions:
- Serve as the primary point of contact and Analytical Project Lead for all quality control activities related to cell therapy products within a matrix-oriented project organization structure.
- Collaborate closely with operative quality control teams to oversee QC-related project timelines, deliverables, and risk management, ensuring successful outcomes that meet stringent quality standards.
- Author and review essential project-related quality documents, including validation protocols and reports, stability documents, specifications, and tech transfer documents. Provide critical content for submission-related activities.
- In conjunction with the project management office, ensure the meticulous planning of QC-related analytical project activities. This includes defining project scope, coordinating tasks across teams with R&D, Manufacturing, Quality Assurance, Regulatory Affairs, and other departments, as well as monitoring progress against milestones, overcoming obstacles and maintaining clear and proactive communication with stakeholders to ensure adherence to project timelines and quality standards.
- Lead GMP-compliant analytical technology transfers from Bergisch Gladbach to other global cell factories within the Miltenyi network, ensuring comprehensive knowledge sharing and careful consideration of site-specific requirements.
Qualifications
- A completed degree in Pharmacy, Biology, Biotechnology, or a closely related field is mandatory. A PhD in a relevant discipline is highly advantageous.
- Extensive experience in project management within the biotech or pharmaceutical industries is required, with a particular emphasis on GMP-regulated Quality Control or analytical development environments.
- Comprehensive understanding of GMP environments and Health Authority expectations is essential. In-depth knowledge of relevant ICH guidelines and experience in dossier compilation is highly desirable.
- Exceptional communication skills are imperative, demonstrating the ability to articulate complex topics clearly and professionally to diverse audiences. The capacity to assert oneself constructively in challenging situations is crucial.
- A strong conceptual, analytical, and structured working approach is required, coupled with a solution-focused mindset and unwavering motivation.
- Fluency in both German and English (written and spoken) is non-negotiable, as the role demands clear and precise communication of complex topics across various stakeholder groups.
- The successful candidate must exhibit a proactive and flexible approach to work, capable of navigating and excelling in a dynamic, fast-paced environment.
Additional Information
What we offer
- Flexible and remote work: Enable time management on your terms
- Diversity: International teams and cross-border intercultural communication
- Room for creativity: It’s the most clever solution that we always strive for
- Health & Sport: We offer a wide range of corporate sports activities and health provision
- Miltenyi University: A clever mind never stops learning, take advantage of our inhouse Training Academy
Diversity is the bedrock of our creativity.
Our mission: To innovate treatments and technologies and tackle the world’s most serious health challenges. And that’s why we connect the dots –across various disciplines, linking different perspectives, skills, and abilities.
You and your talent are welcome here in our inclusive and collaborative environment. So come as you are. Regardless of gender, sexual identity, age, ethnicity, religion or disability.
Become part of our team and focus on pushing the borders of medicine.
Contact us
If you have the skills and qualifications for this position, please use the link to send us your details (application letter, curriculum vitae, references and certificates). Please give us some idea of when you can start and the kind of salary you are looking for, outlining the reasons you have made this application.
