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Process Development Chemist
2 months ago
As a Process Development Chemist at AtomVie Global Radiopharma Inc., you will play a vital role in the development of our clinical and commercial radiopharmaceutical products. Reporting to the Lead, Radiopharmaceutical Technology, you will apply your technical expertise and experience in radiochemistry and process chemistry to support current products and future drug development within our portfolio of Contract Development and Manufacturing Organization (CDMO) functions.
The Process Development Chemist will work as part of a highly skilled group of individuals employing industry-leading development activities within the radiopharmaceutical industry while ensuring regulatory compliance, site safety, and radiation protection guidelines are continuously upheld.
Key Responsibilities- Technical Expertise: Act as a technical expert in Good Manufacturing Practice (GMP) process development for our clinical and commercial portfolio.
- Experiment Design and Execution: Design and conduct radiochemistry experiments for clinical and commercial drug developments.
- Data Analysis and Conclusion: Critically evaluate data, determine appropriate conclusions, and a plan of action in collaboration with internal stakeholders to develop phase-appropriate GMP production processes.
- Project Updates: Provide project data and progress status updates to management and clients.
- Process Development: Work with cross-functional teams on the development of synthesis, purification, formulation, and aseptic filling processes, including process transfer, scale-up, validation, and launch activities.
- Documentation and Reporting: Support the preparation and review of written procedures, batch records, experimental protocols, and reports, specifications, and qualification/validation protocols.
- Safety and Compliance: Emphasize safety in new and existing design and safe practices in all experimental activities for all staff members.
- Regulatory Compliance: Conduct work according to best practices and, where appropriate, regulatory guidance, GMPs, established business processes, and protocols, and applicable standard operating procedures.
- Education: At minimum, a Bachelor of Science in chemistry, radiochemistry, biochemistry, or an equivalent discipline with at least 2 years of relevant laboratory experience and expertise in process development and formulation. A Master's or Ph.D. in the aforementioned disciplines is preferred.
- Experience: Strong knowledge in chemistry, process chemistry, or aseptic manufacturing experience in a pharmaceutical setting is considered an asset.
- Skills: Knowledge of validation principles, technology transfer of manufacturing processes, and GMP concepts is highly desirable.
