Lab Expert - Analytical Science & Technology for cell-based therapies (m|f|d)

Miltenyi Biotec; Bergisch Gladbach; Vor Ort; EUR 90.000 - 130.000; Vollzeit

Zusammenfassung

Miltenyi Biotec is seeking an Analytical Science & Technology Expert to drive technology transfers and harmonize analytical procedures across our manufacturing network, including flow cytometry and PCR for cell therapy products.

You will supervise all procedure-related activities, support optimization, and collaborate with QC Operations, MSAT, QA, and Analytical Development to ensure procedures are robust and scalable for global manufacturing.

Qualifikationen

• PhD in biology, biotechnology, pharmacy, (bio-)engineering or comparable field.
• Professional experience in Technology Transfer, MSAT/ASAT, or CMC development would be beneficial, with GMP familiarity as a plus.
• Excellent English and willingness to travel internationally, if needed.

Aufgaben

• Take a key role in ensuring technology transfers and harmonization of analytical procedures across our manufacturing network.
• Support robustness and scalability of analytical procedures such as flow cytometry and PCR for cell therapy products.
• Supervise analytical procedure-related activities including training and comparability studies and document in project planning context.
• Drive implementation of analytical procedure optimizations and harmonization within the manufacturing network.
• Collaborate with QC Operations, MSAT, Quality Assurance and Analytical Development teams to ensure analytical procedures are appropriate from early commercial manufacturing.

Kenntnisse

Flow cytometry

PCR

GMP knowledge

Ausbildung

PhD in biology/biotechnology/pharmacy/bio-engineering

Tools

Flow cytometry

PCR

Jobbeschreibung

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 make a significant contribution 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.

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 make a significant contribution 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

As an Analytical Science & Technology Expert at Miltenyi Biotec, you will take a key role in ensuring the technology transfers and harmonization of analytical procedures such as flow cytometry and PCR across our manufacturing network. robustness and scalability of analytical procedures such as flow cytometry and PCR for our innovative cell therapy products. Working at the intersection of science, GMP compliance, and global collaboration, you will also support optimizations, robustness, and scalability of our analytics.

• As Analytical Science & Technology Expert you are highly knowledgeable in our analytical procedures of cell-based Therapies, i.e. flow cytometry, PCR and safety testing.
• You play an active role in extending Miltenyi Biotec's innovative and exciting vision of cell-based therapy manufacturing to our global sites and CMOs in the course of Technology Transfers.
• You contribute substantially to the success of overall transfers by supervising all analytical procedure-related activities including relevant training and comparability studies, including documentation in the context of the overall project planning.
• Within our team, you also drive the implementation of analytical procedure optimizations as well as harmonization within our manufacturing network.
• You closely collaborate with our QC Operations, MSAT, Quality Assurance as well as Analytical Development teams to ensure that our analytical procedures are appropriate and suitable from early commercial manufacturing (Analytical Procedure Life Cycle Management).

Qualifications

• You hold a PhD in biology, biotechnology, pharmacy, (bio-)engineering or comparable field.
• Professional experience in Technology Transfer, MSAT/ASAT, or CMC development would be beneficial. A solid understanding of GMP and relevant regulatory frameworks is a plus.
• Enthusiasm in taking responsibility and a hands-on mentality in a dynamic environment.
• Practical experience with PCR and flow cytometry is beneficial.
• Your proactive mindset, combined with hands-on experience in genetic engineering or a related discipline, enables you to take responsibility in a dynamic environment.
• With excellent intercultural communication skills and strong English proficiency, you bring a structured and solution-oriented approach and are willing to travel internationally, if needed.

Additional Information

Diversity is the bedrock of our creativity.

Our mission: To innovate treatments and technologies and tackle the worlds 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.