Scientist Lc Chromatography

Il y a 7 mois

Beerse, Belgique Qplox Engineering Temps plein

**About the company**

Qplox is a fast-growing company offering test and automation engineering. Headquartered in Leuven, with offices in Barcelona and Eindhoven.
Our clients are major multinational enterprises and local companies from automotive, semiconductors, RF, consumer electronics. Our Test automation group offers a one stop shop for design of automated test benches, system integration production, lab automation and data acquisition systems, with a growing focus in IoT sensor networks.
Our consultancy department offers services in RF, semiconductors and electronics design and test, as well as on the crossing roads of Nanotechnology, Bio-Science Engineering and Biotechnology.

The department is responsible for Small Molecule Method Development, Method Validation, Method Transfer and support. This includes Active Pharmaceutical Ingredients, Drug Products, Chemical Raw Materials, Starting Materials, Intermediates and In-Process Controls from early development through the lifecycle for commercial products. We also provide analytical support for all regulatory filings (CTA/IND, NDA/MAA, Post Approval Submissions), Inspections and investigations. As well as focused analytical base business support for the Small Molecule (SM) R&D and Manufacturing product portfolio. Finally, we provide development and implementation of Process Analytical Technology (PAT) / New Innovative Analytical Technology Platforms for Small Molecules and Cleaning Validation.

**This will include**:

- You are responsible for the planning, coordination and execution of the analytical experimental work (method development, validation, transfer) the main part of this experimental work focusing on analytical methods for assay/purity, content uniformity, ID, moisture and solvents.
- You independently lead multiple assigned projects: establishes priorities, checkpoints, and time frames in line with the project
- and team objectives/deliverables.
- You will collaborate closely with colleagues from analytical, API and Drug product development.
- You advise and inform management and stakeholders of technical requirements, about potential scientific challenges and risks, prioritization or resources conflicts and makes suggestions to resolve or mitigate these.
- You initiate ideas to improve the support and efficiency of the analytical method development/validation/transfer activities for the R&D portfolio.
- You ensure that applicable guidelines, established operating procedures and safety regulations adhering to company work standards are being followed.
- You author and review technical reports, protocols and standard operating procedures.
- You maintain knowledge of Good Manufacturing Practices (GMP) and ICH Guidelines.

Location**:Beerse**

You will also bring:

- In-depth technical knowledge and experience for developing/validating and transferring analytical methods in support of the R&D project portfolio with a major focus on techniques such as Liquid Chromatography (UHPLC), Mass Spectrometry (Single Quad) is required.
- Knowledge and/or experience with oligonucleotide/oligopeptide Analytical method development is preferred.
- You can work independently, though you are also an excellent collaborator and like to work in a multidisciplinary, inter departmental and cultural divers’ context.
- You can oversee projects in a professional way with respect to deadlines and with a good sense of urgency.
- You ensure high scientific quality standards for experiments and take on responsibility for these experiments.
- You are a prudent risk-taker, who thinks of innovative and creative solutions.
- Fluent in English.

**We offer**

An attractive salary package with extra benefits. A high tech, multicultural and young ambient. A fast track in a growing company. Formation in multidisciplinary environment plenty of learning opportunities.

**Job Types**: Permanent, Full-time

**Education**:

- Bachelor's (required)

**Language**:

- English (required)

Work Location: In person

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