Msat Investigator Associate

3 maanden geleden

Amsterdam, Nederland HAYS Voltijd

Amsterdam | Belgium | MSAT Investigator Associate | Cell culture | GMP | CAPAs | Investigations | 1048219 |
**Your new company**
Our client, in Belgium, is a global biotechnology company dedicated to treating and curing life-threatening diseases. They develop cell therapies across a diverse range of technology platforms, including autologous and allogenic chimeric antigen receptor T - cell and NK cell - based immunotherapy. They are committed to improving the lives of patients worldwide at multiple sites and their goal is to reimagine healthcare and to deliver transformative treatments in the fields of oncology and cell therapy.

**Your new role**
We are seeking a dynamic MSAT Investigator Associate to join our Manufacturing Science and Technology (MS&T) team at our cutting-edge facility in Ghent. This role involves leading critical manufacturing studies, enforcing GMP standards, and driving continuous improvements. If you have a passion for problem-solving, a keen scientific mind, and a desire to work in an innovative environment, we want you on our team
As an MSAT Investigator Associate, your responsibilities will include:

- Conducting thorough investigations within our manufacturing process to ensure timely and safe product releases, adhering to GMP standards and regulatory requirements.
- Collaborating with multidisciplinary teams to identify and resolve root causes of incidents, implementing robust corrective and preventive actions (CAPAs).
- Serving as the primary contact for regulatory agencies during inspections, defending investigation strategies and reports).
- Championing research processes and methodologies, implementing process improvements based on lessons learnt and leading to challenging trend investigations to reduce recurring deviations.
- Liaising with various stakeholders to ensure efficient execution of process validation and production schedules.
- Facilitating seamless knowledge transfer between functions and locations for effective problem-solving.

**What you'll need to succeed**
- Minimum of 3 years of operational experience in a cGMP environment within the biotech or pharmaceutical industry, preferably in cell and gene therapy.
- Thorough knowledge of cGMP regulations and FDA/EU guidelines related to ATMPs. Excellent scientific writing skills.
- You are fluent in Dutch or English, with strong oral and written communication skills.
- Strong analytical, problem-solving, and relationship-building skills
- Positive, ability to meet critical deadlines in a fast-paced environment, and results-oriented attitude

**What you'll get in return**

**What you need to do now**
1048219

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