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Head of CMC Development

Job
Head of CMC Development
Location
Woburn, MA
Employment Type
Full Time
Starting
ASAP
Required qualifications
  • BS/MS or PhD in a Chemistry, Biology or Chemical Engineering. Advanced graduate degree (MS or PHD are preferred)
  • Industry experience of 5 years or more in relevant CMC expertise in one or more area including analytical, chemical process development, drug product development or manufacturing technology
  • Documented evidence of prior successful CMC project leadership from early phase, late phase leading to commercialization and regulatory approval.
  • A minimum of 5 years of experience in CMC project management, development, scale-up and clinical/commercial development and manufacturing in the biotechnology or pharmaceutical industry
  • Experience in leading and direct management of research, analytical laboratories, process development, and manufacturing
  • Documented experience in achieving regulatory approval of new drugs, generic drugs, or biologicals
  • Good understanding of cGMP and FDA regulations and guidelines relating to CMC-related areas
  • Knowledge of global CMC-related regulatory requirements and guidelines
  • Excellent leadership, managerial and communications skills in a cross-functional environment
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    Email: [email protected]