About the Role:

• The Scientist role in Commercial Process Development will be part of the global method implementation team responsible for method transfer and method validation to Quality Control for pivotal and late stage programs.
• The role will provide technical support for critical large projects.
• This individual may support clinical and commercial locations throughout the company under the guidance of project leads.

Responsibilities:

• Conduct method transfer and method validation processes for pivotal and late stage programs
• Provide technical support for critical large projects
• Author protocols and reports according to regulatory and industry guidelines
• Analyze data and provide technical support for projects
• Support clinical and commercial locations under the guidance of project leads

Education Qualification:

• Master’s degree and 2 years of Operations or Scientific experience  Bachelor’s degree and 4 years of Operations or Scientific experience  Bachelor's in Biochemistry, Analytical Chemistry, Physical or Life Sciences

Required Skills:

• Strong understanding of analytical methods within platforms such as Chromatography, Bioassay, PCR, Microbiology, Immunoassay, CE, Gel, Device, Viral, and General
• Direct experience with method transfer and method validation processes in a Pharmaceutical or Biotechnology Company
• Knowledge of analytical methods/technologies used in biologic and synthetic development and manufacturing 
• Excellent written and oral communication skills