Job description
About the Role
We are seeking a Radiochemist to support the development of clinical-stage radiopharmaceutical assets. You will be responsible for managing the development activities required to ensure that manufacturing and QC procedures meet corporate and regulatory requirements to support clinical trials, regulatory submissions, and the transition to commercial-stage manufacturing.
This position is ideal for radiochemists with hands-on GMP manufacturing experience who are comfortable in a fast-paced environment and motivated to contribute to the next generation of radiopharmaceutical drugs.
Key Responsibilities
* Interface with key internal and external stakeholders, including CMOs, to manage the development of manufacturing and QC procedures for clinical-stage radiopharmaceutical assets in compliance with applicable GMP regulations.
* Manage the development and validation of manual and/or automated manufacturing procedures.
* Manage the development and validation of non-compendial QC methods as required.
* Prepare and review development reports, validation protocols/reports, method transfer documents, and other technical documentation.
* Support regulatory filings by contributing to CMC sections for INDs, NDAs, BLAs, and foreign equivalents.
* Draft and maintain SOPs for manufacturing and QC procedures.
* Support method transfers to external manufacturing partners.
* Participate in the streamlining, optimization, and scale-up of manufacturing procedures in preparation for commercial supply.
* Provide technical support for manufacturing and QC procedures across all product lines as needed.
* Ensure all documentation is consistent with the Quality Management System (QMS) and general principles of GMP manufacturing.
Profile
Education & Experience
* Bachelor’s degree in Chemistry, Radiochemistry, Pharmaceutical Sciences, Chemical Engineering, or related field plus ~5 years of relevant experience,
or Master’s degree plus ~3 years of experience,
or PhD plus ~2 years of experience.
* Practical radiochemistry experience is required.
* Proven experience developing HPLC, TLC, or GC QC methods for radiopharmaceuticals is required.
* Experience working in GMP-compliant manufacturing environments is required.
* Strong written and verbal communication skills in [English / local language] are required.
Nice to Have
* Experience working with radiometals.
* Experience with conjugation and radiolabeling of biologics (e.g., antibodies, peptides).
* Experience with method development and validation to support regulatory filings (IND, NDA, BLA, etc.).
Soft Skills
* Strong problem-solving and analytical mindset.
* Ability to work independently while collaborating effectively in cross-functional teams.
* High attention to detail and quality orientation.
* Ability to manage multiple priorities in a dynamic, fast-paced environment.
Why joining us?
Rapid growth: Amaris has doubled its workforce in Belgium in two years, providing numerous growth opportunities for employees.
Prestigious projects: Candidates will work with renowned clients in the pharmaceutical, biotechnology, and European institutions sectors on impactful missions.
International environment: An agile and dynamic structure promotes intrapreneurship and meritocracy, with international exposure at the heart of Europe.