Associate Director, Analytical Development

Location
92121, San Diego
Posted
Jun 20, 2018
Required Education
Bachelors Degree
Position Type
Full time

SUMMARY: 

The Associate Director will lead method development for mRNA drug substance characterization and release. They will be responsible for leading analytical method development, validation, test method transfers to QC labs, and stability evaluations. The candidate will also support quality and regulatory teams to provide relevant documentation and draft sections of regulatory filings. The candidate will be required to resolve complex method development challenges through collaboration with the process development, manufacturing and analytical teams. They will work closely with a team of highly motivated scientists and engineers in the RNA process development and analytical sciences group to enable successful GMP manufacture and release of mRNA drug substance.

 

REQUIREMENTS:

  • Degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or related field: Ph.D. with 7+ years, MS with 12+ years, or BS with 15+ years of relevant method development or analytical experience in biotechnology industry
  • A broad understanding of analytical method development for biologic or nucleic acid drug substance
  • Demonstrated ability to manage test method transfer to QC labs
  • Direct experience with analytical method development, validation and stability evaluations
  • Technical proficiency of analytical methodologies for drug substance
  • Proven ability to work in a team environment to solve complex technical and validation challenges
  • Experience working with nucleic acid products is a plus
  • Experience with regulatory requirements for pharmaceutical products
  • Knowledge of relevant GMP and quality guidelines
  • Experience in providing scientific/technical due diligence support for business development activities
  • Excellent oral and written communication skills
  • Travel to external QC labs will be required to support test method transfer