Research Scientist, Small Molecule Analytical Development, Analytical Development and Operations

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Job Description
 

Research Scientist, Small Molecule Analytical Development, Analytical Development and Operations

The Research Scientist role is part of the Analytical Development (AD) group in the Analytical Development and Operations (ADO) organization. AD is primarily responsible for developing phase-appropriate methods to support clinical progression of small molecule drug candidates, supporting process chemistry and formulation development, and generating data for regulatory submissions.  The Research Scientist will be part of a technical team supporting analytical method development and characterization.

Job Responsibilities:

• Develops analytical methods and masters technologies to ensure the successful progression of small molecule assets from nomination through marketing application and commercial launch.

• Performs physical and chemical characterization of small molecule drug candidates using an array of analytical techniques.

• Troubleshoots lab issues and provides technical guidance in quality investigations.

• Uses data to draw conclusions and make recommendations on method development strategy.

• Champions scientific innovation and technology to enable analytical method development while seeking opportunities to expand and develop capabilities to support projects and departmental goals.

• Collaborates closely with the Analytical Project Strategy and Technical Operations teams. Supports cross-functional groups, including formulations and process chemistry.

• May guide junior analysts in experimental design and data analysis.

• Presents results of studies to team and potentially external groups. Communicates results in laboratory notebooks, reports, or presentations.

• May support regulatory filings by providing data, authoring, or review of analytical method sections.

• Responsible for compliance with applicable corporate policies and procedures.

Education and Experience:

• Minimum: PhD in chemistry, analytical chemistry, chemical engineering, or closely related discipline with 0+ years of experience in pharmaceutical and/or biotechnology industry. 6+ years of experience with an MS, or 8+ years with a BA/BS with similar training and experience.

• Preferred: PhD in chemistry, analytical chemistry, chemical engineering, or closely related discipline with 1+ years of experience in pharmaceutical and/or biotechnology industry. 10+ years of experience with an MS, or 12+ years with a BA/BS with similar training and experience.

• Hands-on experience in design and execution of laboratory experiments.

• Demonstrated sample preparation, modern chromat