API Manufacturing Lead (Trasis Inc)

Trasis; Ans; Sur place; EUR 65 000 - 90 000; Plein temps

Résumé du poste

Trasis seeks a scientifically strong professional to drive API synthesis process implementation and on-site GMP-compliant production support. You will supervise initial production activities, ensure proper execution and documentation, and coordinate with Belgian teams to align practices across sites.

You hold a Master’s or PhD in Pharmacy or Chemistry, have GMP experience, and are fluent in French and English. A hands-on, autonomous, solution-focused mindset is essential.

Qualifications

• Master’s or PhD in Pharmacy or Chemistry required, with organic/chemical process focus.
• GMP experience essential and regulatory awareness mandatory.
• Strong knowledge of analytical techniques such as GC and HPLC.
• Proven ownership, resourcefulness, and ability to drive initiatives.
• Solution-oriented mindset with troubleshooting and operability skills.
• Committed to quality, compliance, and regulatory adherence.
• Hands-on mindset, autonomy, pragmatism, and proactive coordination.
• Fluent in French and English; API synthesis experience is a plus.

Responsabilités

• Contribute to API synthesis process implementation at the US site.
• Supervise initial production activities in GMP-compliant settings.
• Ensure proper execution of production steps and documentation.
• Coordinate on-site operations related to API production and resources.
• Monitor production performance and support technical issue troubleshooting.
• Support material flow management and supply availability.
• Ensure quality, safety, and regulatory compliance on site.
• Coordinate with Belgian teams and support the US Sales process if needed.

Connaissances

GMP experience

Analytical techniques

Coordination & communication

French & English fluency

Formation

Master’s degree in Pharmacy or Chemistry

PhD in Pharmacy or Chemistry

Outils

GC

HPLC

Description du poste

Responsibilities

API Manufacturing & Process Implementation

• You contribute to the implementation of API synthesis processes at the US site (transfer, adaptation, small-scale industrialization).
• You supervise initial production activities in compliance with quality and GMP standards.
• You ensure proper execution of production activities (preparation, synthesis, cleaning, documentation.

Local Operations Coordination

• You coordinate on-site operational activities related to API production (planning, priorities, limited resources).
• You monitor production performance and support troubleshooting of technical issues.

Supply & Logistics Support

• You support the management of material flows related to production (raw materials, consumables, shipments).
• You anticipate operational needs and contribute to securing supply availability.
• You coordinate with group supply teams to ensure smooth operations.

Quality, Safety & Compliance

• You ensure compliance with quality (GMP), safety, and regulatory requirements on site.
• You contribute to the implementation of procedures and best practices.
• You ensure proper documentation and traceability of activities (batch records, controls, etc.)

Interface with Belgium

• You ensure close coordination with Belgian teams (Chemistry R&D, Production, Quality, Supply).
• You provide technical and scientific support to the US Sales team throughout the sales process if needed.
• You facilitate knowledge transfer and ensure alignment of practices between sites.
• You elevate needs, risks, and critical issues.

Profile

• You have a Master’s degree or PhD in Pharmacy or Chemistry (organic, pharmaceutical, or chemical processes).
• You have experience in a GMP environment.
• You have a good knowledge of analytical techniques (e.g. GC, HPLC,…).
• You have a demonstrated ownership, resourcefulness, and ability to drive initiatives.
• You have a solution-oriented mindset with a strong ability to troubleshoot and address technical and operational challenges.
• You have a strong commitment to quality, compliance, and adherence to regulatory requirements.
• You have a hands-on mindset, autonomy, and pragmatism.
• You have strong coordination and communication skills.
• You are fluent in French and english.
• An experience in API synthesis will be considered as an asset.

Do you want to become a major player in the global fight against cancer ?

At Trasis, we give you the opportunity to work with cutting-edge technologies and to contribute to the improvement of cancer diagnosis and therapy techniques. Through your actions, you will have the opportunity to have a positive impact on the services provided to users and patients.

The opportunity to participate in building and improving processes in a growing company.

We offer a young and friendly work atmosphere, a flexible and dynamic environment.

An attractive and flexible salary according to your experience and performance, with extra-legal benefits.