API Manufacturing Lead (Trasis Inc)

As an API Manufacturing Lead, you are is responsible for supporting the launch and coordination of API manufacturing activities at the US site, as part of developing initial manufacturing capabilities. You contribute to the implementation of API synthesis processes, coordinates local production operations (first batches), and acts as the main operational interface with teams in Belgium (R&D, production, supply, and quality), ensuring an efficient and compliant start of activities.

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 escalate 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.