SUMMARY
This Global Radiopharma is currently looking for an Analytical Development expert to join their R&D leadership team. The ideal candidate will have a strong track record of innovation & prior experience in radiopharmaceutical and nuclear analytical science technology.
RESPONSIBILITIES
- Provide strategic & technical leadership for the Analytical Development team while collaborating with relevant R&D/CMC depts, fostering a culture of innovation, collaboration, and excellence.
- SME for analytical method development, optimization, qualification & validation to support the advancement of the lead programs in the pipeline
- Manage CDMOs, setting clear expectations and goals, and conducting performance assessments and oversight of internal and external stakeholders to facilitate efficient technology transfers.
- Evaluate & implement (when deemed necessary) state-of-the-art technologies and methodologies to enhance analytical capabilities for radiopharma compounds.
- Ensure accurate and timely documentation of analytical activities, including method development reports, validation protocols, technical reports, & FDA regulatory filing (IND/IMPD/BLA, etc.).
QUALIFICATIONS
- PhD in Analytical Chemistry, Pharmaceutical Sciences, or a related field with 8+ years of experience in the pharmaceutical industry
- Experience in Radiopharmaceuticals analytical methods (minimum 3 years) in development of radiopharmaceuticals (alpha therapy will be a plus), with a proven track record in analytical method development and technology transfer.
- Strong leadership and people management skills (Prior experience managing CRO/CMO's is a PLUS).
- Excellent organizational and project management skills, with the ability to prioritize and multitask effectively.
- Familiarity with relevant regulations (FDA, EMA), standards, and guidelines, including those relating to quality, safety, and environmental impact.
