Analytical Principal Scientist; Analytical team lead

Role Summary

Analytical Principal Scientist (Analytical team lead) based in Cambridge, MA. Responsible for providing and coordinating analytical support to the chemistry teams and ensuring the timely completion of analytical deliverables within Global CMC Development’s small-molecule platform.

• Working with project team members and other scientists to develop analytical strategies that meet the evolving needs of projects
• Develop specific and robust analytical methods mainly on small molecules using equipment including HPLC, UHPLC, GC, and be responsible for validating the methods when necessary
• Coordinate the analytical work for projects this role is responsible for
• Ensure the appropriate allocation of resources on projects in accordance with the priority of the projects and studies
• Represent the analytical group in late development CMC projects
• Ensure timely completion of analytical deliverables (e.g., draggability assessment, specifications, stability program, reference substances, etc.)
• Author or review analytical development technical reports
• Ensure good communication and cooperation among different functional groups, including CMC Dossier, Regulatory CMC, Research Platform, and Manufacturing
• Promote networking with internal or external scientific partners including subcontractors

• Required:
  
  A Master’s degree or equivalent in Analytical Chemistry or related field with a minimum of 8 years, or a PhD with minimum of 5 years of experience in the pharmaceutical/biotech industry. A PhD in Analytical Chemistry is preferred.
• Required:
  
  Extensive experience in analytical method development and validation
• Required:
  
  Ability to operate independently and to prioritize
• Required:
  
  Familiarity with cGMP and regulatory requirements on analytical methods
• Required:
  
  Prior CMC project management experience
• Required:
  
  Excellent communications skills
• Preferred:
  Ability to propose course of action and to provide strong advocacy in CMC team meetings
• Preferred:
  Having a record of success in CMC project management
• Preferred:
  Having working knowledge of synthetic chemistry and pharmaceutical development
• Preferred:
  Consistent record of collaboration with scientists and other stakeholders at external enterprises
• Preferred:
  Advanced scientific network in the industry and academia
• Preferred:
  Record of patents and publications
• Preferred:
  Record of adhering to and promoting lab safety practices

• Master’s degree or equivalent in Analytical Chemistry or related field with extensive experience, or PhD in Analytical Chemistry preferred