Radiochemist Job at Amaris Consulting (Seneffe)

Job Description

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.

Job Responsibility

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.

Requirements

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.).

What we offer

Rapid growth
Prestigious projects
International environment
Equal opportunity workplace
Inclusive working environment.

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Radiochemist

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