Analytical Development Scientist

il y a 4 semaines

MontSaintGuibert, Belgique Cellistic Temps plein

Within our Cell Therapy team in Mont-saint-Guibert (Belgium) there is one position immediately available for a Production Technician.

***:
**The position**:
As a 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) analytical CMC.

The Analytical Development Scientist will be responsible for leading CMC assay development to support hiPSC CMC activities, including characterization methods, in-process controls, release and stability methods for cell therapy products. The Scientist will manage a small team of analytical associate scientists, act as analytical lead on internal and external (client) projects, and will be expected to perform experiments in the laboratory. The Scientist will report to the Director of Analytical Development.

You are autonomous and have a strong focus on innovation and critical thinking, with experience in a service organization or demonstratable leadership and other soft skills needed for commercial projects. You are able to use your expertise in one or several analytical areas to develop and support your team. 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 initiative when challenges occur.

***:
**Responsibilities & Duties**:

- Lead the transfer of early R&D methods and client methods, assay development and qualification
- Prepare experimental planning, including timelines, resource needs and risks
- Draft and review and critical evaluation of protocols, data and reports
- Present data to clients and internal stakeholders
- Ensure good data integrity practices are followed by the team
- Prepare reports and summaries and communicate effectively to internal and external stakeholders
- Set performance and development objectives for team members, and effectively manage their workloads and well-being
- Actively communicate risks and resource needs to the AD Director and project manager
- Generate proposals to resolve key technical hurdles associated with projects
- Support the transfer of methods to stakeholders in R&D, MSAT and QC
- Contribute to effective lab quality and safety management with other AD teams
- Keep up to date of external developments in analytical technologies and regulatory guidelines

**Qualification & Experience**:

- Masters or Ph.D. in biology, bioengineering, biotechnology, or relevant equivalent working experience
- 5-10 years working experience in CMC analytical development in ATMPs and/or vaccines
- Proven track record of independent assay development and qualification (e.g., flow cytometry, qPCR, ddPCR, ELISA, and functional immunological assays). Experience of tech transfer and validation is a plus.
- Familiarity with QbD approaches to method development

**Skills**:

- Good knowledge of statistical approaches to method performance evaluation
- Attentive to detail and possess a problem-solving mindset
- Excellent organization, project and time management skills, including change management
- Good communicator and team-player
- Experience with mammalian cell culture is a plus
- Strong knowledge of regulatory requirements for CMC analytical development
- Good understanding of immunology and stem cell biology
- Can maintain flexibility in a dynamic environment
- Proficiency in English, both written and spoken

**Job Location**:Mont Saint Guibert, 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?**:

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