Senior Scientist, Analytical Development

The mission of Ncardia Belgium is to develop and manufacture hiPSC therapeutics that significantly improve patient outcomes. We are convinced that hiPSC technology is the key to get better, more efficient treatments to patients faster. To achieve this mission, we are building a world-leading manufacturing facility and scalable hiPSC manufacturing platforms that address the production volumes required even for the most prevalent indications. We will know we have succeeded when we can reliably and rapidly operate our manufacturing platforms to generate cell products that consistently produce positive outcomes in patients.

You will join an international and dedicated group of scientists, project leaders and laboratory technicians. We have expertise in bioprocess development, stem cell biology, cell-based assays, and GMP compliance. The selected candidate will report to the Director, Cell Therapy Innovations. If this awakens your interest, please apply and support us to achieve our mission in bringing better therapies to patients faster.

The position

As a Senior Scientist in Analytical Development, your key responsibilities will be to drive development, optimization, and qualification of new analytical methods and equipment associated with hiPSC-based manufacturing processes. You have a strong background in Advanced Therapy Medicinal Product (ATMP) process validation and technology transfer to cGMP manufacturing.

You have a strong focus on innovation and critical thinking, and with experience in a service organization or demonstratable leadership and other soft skills needed for commercial projects. You have a high level of energy that drives you and inspires your colleagues. You thrive in a changing and dynamic work environment, and in a job that requires you to be flexible and take when challenges occur. As part of the job responsibility includes hands-on assay development, the preferred candidate is a motivated researcher with desire to work in a laboratory, including occasional cell maintenance during the weekend.

Responsabilities

• Lead the development, qualification, and at a later phase, validation of analytical methods using high throughput and multidimensional technologies, where necessary
• Perform phenotypic characterization for quality control of cell therapy products
• Participate in technology transfer of methods or processes to QC and/or cGMP manufacturing
• Coordinate work with the scientific team
• Provide scientific background and feedback on results to the scientific team
• Ensure accurate internal data reporting including protocols, technical and scientific reports
• Generate proposals to resolve key technical hurdles associated with projects
• Represent the CTI group internally and collaborate with other disciplines within the company (e.g., manufacturing, business development, QA, project management, etc.)
• Contribute to or lead scientific presentations (customer updates, peer-reviewed publications, white papers, conference presentations) and collaborate with external stakeholders
• Draft and review quality documents such as Standard Operating Procedures (SOPs), work instructions

Qualifications

• Ph.D. in biology, bioengineering, biotechnology, or relevant equivalent working experience
• 5-10 years working experience with mammalian cell manufacturing in an industrial setting
• Strong knowledge of regulatory requirements for current Good Manufacturing Practices (cGMP)
• Proven track record of independent assay qualification / validation and tech transfer (e.g., flow cytometry, qPCR, ddPCR, ELISA, and functional immunological assays)
• Good understanding of immunology and stem cell biology
• Familiarity with QbD/DoE and PAT approaches
• Experience with hypothesis testing and multivariate data analysis statistics
• Familiarity with generation and interpretation of large datasets
• Attention to detail, and problem-solving
• Excellent organization, project and time management skills. Timelines may be demanding
• Capacity to innovate and contribute to company IP
• Good communicator and team-player
• Can maintain flexibility in a dynamic environment
• Proficiency in English, both written and spoken

Job Location:Gosselies, Belgium

Position Type: Full-Time

Start Date:Immediately

We offer you a challenging position in a dynamic biotech company with room for personal growth and development. We provide a competitive salary package based on your education and experience.

Interested?

Send your motivation letter with curriculum vitae to Elodie Noël at careers@ncardia.com