Scientist, Technical R&d Drug Product

il y a 4 semaines

Rixensart, Belgique GSK Temps plein

**Site Name**: Belgium-Rixensart
**Posted Date**: Dec 18 2024

Job Purpose

The Drug Product (DP) Development Scientist works within the Technical R&D - Drug Product.

He/she is responsible for managing the development of drug product by ensuring robust Drug Product processes and by providing state-of-the-art product and process expertise to support the development of vaccines for PI, PII, PIII clinical phases and for the transfer to the manufacturing.

He/she establishes and maintains strong collaboration and interaction both locally and globally with internal (within TRD-DP and TRD) and external (GIO, Quality, Regulatory etc...) partners and contribute to project plans for delivering the expected product and process innovations and knowledge. He/she ensures that the content and quality of regulatory submissions meets the requirements in all markets for the products.

As part of his/her job he/she organizes and participate to the laboratory experiments. He/she defines the project development strategy and, also provides protocols and reports describing the methodology and the results of the lab trials. He/she is responsible of the validation of the strategy and experimental results in dedicated governing bodies.

He/she reports to the Drug product Development senior manager

Key Responsibilities
- Responsible for the conception, design, implementation, and interpretation of scientific and technical data to support TRD DP Development projects.
- Utilizes Quality by Design and other advanced methodologies
- Actively participates and holds responsibility in technical teams (TDT, Task Forces) as representative of DP department and utilizes scientific knowledge and experience to influence project decisions.
- Functions effectively as a core team member on multiple concurrent projects and leads projects and establishes work processes.
- Prepares and presents scientific and development data within Technical R&D and to dedicated governing bodies and technical teams
- Authors and reviews technical protocols and reports in support of various project development stages including the transfer to the manufacturing.
- Communicates effectively within TRD and with external stakeholders.
- Design the experimental work and establishes the precise deliveries in accordance with the process flow and standards in place in the Technical R&D/ Drug product team. Validate the experimental data and writes the documentation (production methods, technical reports, development report, process history files, Process Evaluation )
- Ensures highest ethical standards, good scientific practices and data integrity are implemented in daily scientific activities.
- Reports the projects performance to the Drug Product Associate Director

**_ Why you?_**:
**Basic Qualifications**:

- We are looking for professionals with these required skills to achieve our goals:_
- PhD with 0+ years OR Master degre with 3+ of experience OR Bachelor with 6+ years of experience
- Experience in vaccine development process is required.
- Experience in mRNA and in nanoparticle-based delivery”process development is an asset.
- Good skills in scientific writing are required.
- Must have the ability to work with cross-functional teams and communicate effectively.
- Proficiency in written and spoken English.

**Preferred Qualifications**:

- If you have the following characteristics, it would be a plus:_
- Experience in vaccine formulation development, drug product manufacturing technologies/processes is required
- Very good background in analytics is needed (HPLC, colorimetic methods, Size measurements, SDS-Page)

If you have a disability and require assistance during the course of the selection process, you will have the opportunity to let us know what specific assistance you require in order to make suitable arrangements.

**Why GSK?**

**Uniting science, technology and talent to get ahead of disease together.**

GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this e

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