3 дня назад
Radiochemist (Pharma)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Radiochemist (Pharma): Developing clinical-stage radiopharmaceutical assets with an accent on GMP manufacturing and QC procedure validation. Focus on managing CMC sections for regulatory filings and optimizing manufacturing scale-up for commercial supply.
Location: Belgium
Company
is an independent technology consulting firm providing guidance and solutions to businesses across various sectors, including Life Sciences.
What you will do
- Manage the development of manufacturing and QC procedures for clinical-stage radiopharmaceutical assets in compliance with GMP regulations.
- Develop and validate manual and automated manufacturing procedures and non-compendial QC methods.
- Prepare technical documentation, including development reports, validation protocols, and method transfer documents.
- Support regulatory filings by contributing to CMC sections for INDs, NDAs, and BLAs.
- Draft and maintain SOPs and support method transfers to external manufacturing partners.
- Optimize and scale up manufacturing procedures in preparation for commercial supply.
Requirements
- Education: Bachelor's degree in Chemistry, Radiochemistry, Pharmaceutical Sciences, or Chemical Engineering (plus ~5 years experience), Master's (plus ~3 years), or PhD (plus ~2 years).
- Practical experience in radiochemistry is required.
- Proven experience developing HPLC, TLC, or GC QC methods for radiopharmaceuticals.
- Experience working in GMP-compliant manufacturing environments.
- Strong written and verbal communication skills in English and the 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).
Culture & Benefits
- Rapid career growth opportunities within a fast-growing Belgian division.
- Engagement in prestigious projects with renowned pharmaceutical and biotechnology clients.
- International, agile environment promoting intrapreneurship and meritocracy.
- Inclusive workplace committed to diversity and equal opportunity.
Hiring process
- Brief virtual or phone introductory call to understand motivations.
- Average of three interviews with line managers and future team members.
- Technical assessment or case study depending on the specific role requirements.
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