As a sr. Process engineer global MSAT contractor, you will contribute to advancing CAR-T manufacturing processes and technology transfers within a decentralized manufacturing model. Your expertise will play a key role in ensuring the transition of lab-scale processes into robust, GMP-compliant manufacturing systems. You will face challenges such as process characterization, lifecycle validation, and regulatory documentation, requiring a strong background in cell and gene therapy, automated bioreactors, and GMP manufacturing.
What You Will Do:
- Act: as a subject matter expert on automated CAR-T manufacturing processes and technology transfers.
- Develop: and execute plans for lifecycle process validation activities and product comparability assessments.
- Lead: process characterization studies, including protocol design, data analysis, and technical report preparation.
- Collaborate: with process development and CMC teams to translate lab-scale processes into GMP-ready manufacturing systems.
- Prepare: and review CMC documentation, including validation protocols, comparability reports, and regulatory filing sections.
Joining our team means becoming part of a dynamic and innovative environment where your expertise is valued, and your growth is supported. We offer a range of benefits designed to empower you both professionally and personally.
- Temporary contract for a period of 6 months.
- Part-time role with 16-24 hours per week.
- Opportunity to work on cutting-edge CAR-T manufacturing projects.
- Collaborative and supportive workplace recognizing you as an equal partner.
- Access to diverse projects to expand your expertise across domains.
We are seeking a skilled and collaborative Sr. Process Engineer with expertise in CAR-T manufacturing and a passion for innovation.
- PhD in life sciences, biotechnology, or engineering; 7+ years' experience.
- Proven expertise in cell & gene therapy and GMP manufacturing.
- Experience with process characterization studies and biostatistics tools.
- Strong knowledge of Quality by Design and risk management principles.
- Fluent in English with excellent communication and interpersonal skills.
Located in Oegstgeest, our biotechnology company is dedicated to transforming lives by addressing high unmet medical needs. With a focus on oncology and immunology, we combine cutting-edge science, innovative technology, and collaborative approaches to develop groundbreaking CAR-T therapies, biologics, and small molecules that make a real difference.
What sets us apart is our decentralized CAR-T manufacturing network, a commitment to challenging the status quo, and a culture that values both personal and professional growth. We foster a dynamic, inclusive environment where every team member’s contribution is recognized and celebrated.
Are you ready to join a company that’s redefining the future of medicine?
€8000.00 - €9000.00 monthly