Principal Scientist - CRO

Posted 15 March 2023
Salary Competitive
LocationUnited States of America
Job type Full Time
DisciplineLarge MoleculeCRO & Clinical Operations
Contact NameThomas White

Job description

The Principal Scientist, R&D will be responsible for all aspects of analytical development including characterization for drug substances (DS) and drug products (DP). This position is responsible for performing project leadership for analytical method development for drug substance/product development for release and stability, manufacturing support, and regulatory submissions assistance to clients and subcontractor vendor management.

Principal Scientist - Key Responsibilities
  • Within the R&D group, the Principal Scientist, will be primarily responsible for developing analytical methods for a variety of therapeutic protein candidates.

  • Scope of work will include, but is not limited to, analytical method development, implementation & transfer, biochemical and biophysical characterization of proteins, analytical development technologies, upstream and downstream process development support, data analysis.

  • Project execution and reporting of client projects according to budget and timelines developed by the project team.

  • Phase appropriate development, validation, and transfer of robust analytical methods for starting materials, in-process control, DS and DP testing.

  • Oversee the execution routine R&D testing.

  • Demonstrate attention to detail in the planning, execution, and documentation of experimental work.

  • Write development reports, validation protocols, and ensure their timely delivery and communicate with the GMP team.

Mantell Associates is a specialist Pharmaceutical and Life Sciences headhunting firm. For more information on this role, please contact us at +44 (0)20 3854 7700.