Process Design Expert (m|f|d) Cell & Gene Therapy

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Miltenyi Biotec seeks a Process Design Expert in Global Supply Chain to design, optimize and harmonize core processes, documentation and digital tools for clinical and commercial cell and gene therapy supply. You will be the process mapping SME, translating user needs into clear specifications, supporting qualification and validation, and aligning with QA for audits and compliance. You will drive cross functional alignment with Clinical Development, GSC, QA and Manufacturing to ensure harmonized, scalable processes across clinical and commercial chains. Ideal candidates have a degree in engineering or life sciences, proven GxP documentation experience, and strong process mapping, KPI definition and risk-based thinking, plus GMP interfaces. To apply, tailor your CV to highlight relevant GSC work, SOPs, WIs and RAs, quantify improvements, show collaboration with diverse stakeholders and comfort with digital tools and audits; include salary expectations and availability and confirm onsite work in Bergisch Gladbach.

Company Description

Miltenyi Biomedicine is a biopharmaceutical company committed to advancing personalized cell and gene therapies. We are pioneering groundbreaking therapies for serious life-threatening diseases, and reshaping their accessibility for clinical professionals and patients worldwide with the aim to improve and extend patients' lives. We are currently focusing on difficult-to-treat hematological cancers using CAR-T and other technologies, while also exploring treatments for other diseases.  Our lead candidate, a tandem CAR-T cell product, is currently undergoing pivotal clinical trials on a global scale.  

Join our highly professional team in bringing new medicines to market and ensuring the safety of our pharmacological developments at all stages.  

Job Description

As a Process Design Expert in the Global Supply Chain (GSC), you will design, optimize, and harmonize the core processes, digital tools, and documentation that enable the clinical and commercial supply of our cell and gene therapy products. 

You will serve as the subject matter expert for process mapping, workflow optimization, documentation, and system requirements — ensuring scalable, compliant, and efficient operations in a highly regulated environment. 

• You co‑lead the design, optimization, and implementation of Global Supply Chain (GSC) processes, including process mapping, reengineering, documentation (SOPs, RAs), and continuous improvement activities. 
• The translation of user and business requirements into clear specifications for workflow and work aids is also on your agenda, and you will support equipment & process qualification and validation, as well as implementation. 
• In addition, you oversee regular alignment with QA on GSC‑related processes and documentation, while supporting audits, trainings, and compliance activities (DEVs, CEXs). 
• You contribute to the development, maintenance, and enhancement of digital tools and workflow systems, ensuring usability, compliance, and scalability. 
• As an integral part of a team of process design experts, you drive cross-functional alignment and continuous improvement with the Clinical Development and Commercial team, GSC team, QA, Manufacturing, and you ensure harmonized, consistent, compliant process execution across clinical and commercial supply chains. 

Qualifications

• You hold a university degree in engineering, life sciences, supply chain/operations, or a related field. 
• You bring proven experience in process design and GxP documentation (SOPs, Work instructions, Risk assessments) within pharma, biotech, or another regulated environment. Management consulting experience is a plus. 
• You have a strong operational excellence skill set (process mapping, KPI definition, risk-based thinking, root cause analysis) with the ability to translate complex operations requirements into clear, structured, and auditable workflows. 
• Additionally, you have hands-on experience with commercial or clinical supply chain processes (e.g., planning, CMO oversight, distribution, and GMP quality interfaces). 
• You are an effective communicator who enjoys working with diverse stakeholders across functions, and you are reliable, detail‑oriented, and work with a proactive, solution‑oriented mindset. 

Additional Information

What we offer    

• Working with free and self-determined time management, also mobile working   
• An intercultural environment characterized by diversity and flat hierarchies   
• Freedom to contribute creatively and play an active role in shaping the company   
• Individual further training in our Miltenyi University as the core of the Miltenyi DNA   
• 30 days of vacation, discounted ticket to Germany, (e)-bike leasing, capital-forming benefits, company pension plan, disability insurance, canteen, and much more.  

 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.  

We look forward to your application  

If you want to work in an open, creative and supportive team, this is the place for you. We look forward to receiving your application along with your salary expectations and availability.