PD/MSAT Expert

Cryoport Systems is the life science industry’s most trusted provider of supply chain solutions for temperature-sensitive materials, serving biopharmaceutical, IVF and surrogacy and animal health organizations around the world. Cryoport Systems' proprietary Cryoport Express® shippers, Cryoportal® Logistics Management Platform, leading-edge Smartpak™ Condition Monitoring System and geo-sensing technology paired with unparalleled logistics expertise and 24/7/365 customer support, make Cryoport Systems the end-to-end temperature controlled supply chain partner that you can trust.

We are looking for an enthusiastic PD/MSAT Expert to join our Process Development (PD) & Manufacturing Science and Technology (MSAT) team. This role is crucial in optimizing cryopreservation processes for autologous and allogeneic cellular therapies, bridging process development, technology transfer, and manufacturing support.

What we expect from you :

Process Development

• Lead process development projects with a Quality by Design (QbD) approach, including troubleshooting and integrating new technologies.

• Design, execute, and analyze experimental studies on cryopreservation processes for internal and external projects.

• Develop and maintain scientific documentation, including protocols, technical reports, and scientific publications.

• Provide scientific input and interpretation of experimental data.

• Stay up to date with scientific literature and emerging technologies in the field of cell and gene therapy.

MSAT & Manufacturing Support

• Ensure technology scouting, identifying process improvement opportunities and implementing them when relevant.

• Support process monitoring, data mining, and product/process analytics.

• Maintain GMP compliance and align with FDA/EU regulatory guidelines.

• Draft and review investigations, risk assessments, CAPAs, and Change Controls.

• Evaluate major deviations and their impact on product quality.

• Support the IntegriCell platform for customer process evaluations and tech transfers.

• Provide technical expertise and training to internal teams and external partners.

• Implement and support technologies across Cryoport Systems sites (up to 10% travel required).

We're looking for someone with :

• PhD in Biology, Bioengineering, Biomedical Engineering, or related fields.

• Minimum 3 years of experience in biotech/biopharma operations, ideally within MSAT, technology transfer, or process industrialization.

• Strong expertise in cryopreservation, process development, and cell & gene therapy manufacturing.

• Solid knowledge of cGMP regulations and FDA/EU guidelines.

• Experience in scientific writing, data analysis, and process optimization.

• Strong scientific problem-solving and analytical skills.

• Excellent scientific writing and data interpretation abilities.

• Fluent in French & English (B2 minimum).

What we offer :

Our offices in Villers-le-Bouillet (Belgium) offer a modern and ergonomic workspace, ideally located between Liège and Namur, with easy highway access. Since moving into our brand-new facilities in November 2023, we’ve created a comfortable & ergonomic environment. We foster a friendly and engaging atmosphere, regularly organizing breakfasts and team events because we believe a positive work environment matters. As part of a global group, you’ll operate in an international environment, using English daily to collaborate across sites, broadening your perspective on different cultures and ways of working. We offer a competitive salary with extra-legal benefits (meal vouchers, hospitalization insurance, equity and more). Most importantly, you'll contribute to a meaningful mission—advancing therapies in the fight against cancer.

If you are an expert in process development and MSAT, passionate about driving innovation in cryopreservation, and ready to contribute to cutting-edge cell and gene therapy advancements, we’d love to hear from you.