Senior Scientist, Analytical Development

Other responsibilities

• Supervise the work of Assay Development Scientists or Technicians
• Analytical Development (AD) representative for cross function meetings/projects with manufacturing, Quality Assurance (QA), Regulatory Affairs and external partners.
• Provide AD review and approval of SOPs, risk assessments, protocols and reports.
• Provide regular updates of AD group activities to the Chief Operating Officer and other Replimune senior management.

Educational requirements

• Education will be appropriate to specific job requirements. The following educational requirements are a minimum:
• B.A or B.S. degree in a relevant biological science. M.S., Ph.D. or other post-graduate degree in biochemistry or related science is preferred

Experience and skill requirements

• Training and experience will be appropriate to specific job requirements. The following categories will be assessed in each case:
• 5-10 years industry experience, preferably in a cGMP Quality environment
• Experience working in a GMP testing environment with an understanding of regulatory requirements and trends related to analytics and product development.
• Thorough understanding of current regulatory requirements and practical experience of QC testing in support of cGMP operations
• Ability to interface effectively with management and other groups or project teams
• Computer processing literacy and experience in statistical analysis
• Excellent verbal and written communication skills
• Good organizational skills

About Replimune