Analytical Development Scientific Lead (Radiopharma)
Company: EPM Scientific - Phaidon International
Location: Boston
Posted on: October 19, 2024
Job Description:
SUMMARYThis 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.
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Keywords: EPM Scientific - Phaidon International, Plymouth , Analytical Development Scientific Lead (Radiopharma), Other , Boston, Massachusetts
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