Analytical Project Lead - Quality Control (m|f|d)

Company Description

For more than 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 4,900 experts from over 70 countries contribute to our sustainable success.

Job Description

Join us in driving the future of innovative cell-based therapies at Miltenyi Biotec, where we develop groundbreaking treatments for cancer, autoimmune, and rare diseases.

As an Analytical Project Leader in Quality Control, you will play a key role in turning cutting-edge science into real-world medical solutions.

• What You’ll Do
• Within a matrix-oriented project organization structure, you will serve as primary point of contact and analytical project lead for all international quality control activities related to cell therapy products.

You will work closely together with the operative quality control teams, overseeing QC related project timelines for international roll-out, deliverables, and risk management to ensure successful outcomes.

• You will take resonsibility for the international transfer and implementation of QC testing strategies for commercialized cell therapy products across Miltenyi sites and point-of-care centers, ensuring consistent quality standards worldwide.
• In collaboration with cross-functional stakeholders, you will author and review critical quality documentation, including validation protocols and reports, stability documents, specifications, and technology transfer packages.

In addition, you will provide QC expertise and content for regulatory submissions, particularly for international markets beyond Europe and the United States.

• Together with QC and Quality Assurance colleagues, you will ensure the global comparability and equivalency of analytical testing for cell therapy products, maintaining alignment with approved filings and regulatory requirements across different regions.
• Partnering closely with the Project Management Office, you will coordinate QC-related project activities across R&D, Manufacturing, Quality Assurance, Regulatory Affairs, and other functions.

You will define project scope, monitor progress against key milestones, proactively address challenges, and ensure transparent communication to keep projects on track.

• Based on your level of expertise and growing professional development at Miltenyi, there is a pathway to take on a leadership role within the Quality Control team, where you can influence strategy, mentor colleagues, and drive key initiatives.

Qualifications

• What We’re Looking For
• You hold a Master's degree in Pharmacy, Biology, Biotechnology, or a related life sciences discipline. A Ph D is considered an advantage.
• Several years of experience leading cross-functional projects within the biotechnology or pharmaceutical industry have equipped you with a strong understanding of complex development and quality environments, ideally within GMP-regulated Quality Control or analytical development.
• Through your excellent communication and stakeholder management skills, you build trusted relationships across functions, confidently navigate challenging situations, and drive alignment among diverse teams.
• A structured, analytical, and solution-oriented mindset enables you to assess complex challenges, develop pragmatic solutions, and successfully move projects forward.
• Fluency in both German and English, written and spoken, allows you to clearly communicate scientific and technical topics to a wide range of stakeholders.

Additional language skills are an asset.

• Willingness to travel internationally supports your collaboration with global teams and your involvement in technology transfer and implementation activities across Miltenyi sites and partner locations.
• 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.