Research Scientist

Job Description

Position Description:

This position will support manufacturing and process chemistry activities through analytical method execution, validation and transfer in compliance with all applicable guidelines.

Essential Functions:

• Perform testing of raw materials, intermediates, in-process samples and APIs with minimal guidance using lab instrumentation.
• Participate in method transfer activities, including writing protocols and reports.
• Participate in method validation execution.
• Actively participate on project teams.
• Actively participate in investigations, problem solving, and troubleshooting.
• Prepare and present data summaries (written and oral) as necessary. Present to cross functional teams and effectively communicate critical analytical issues and solutions.
• Operate analytical instrumentation and equipment as per established procedures.
• Communicate openly within the group to provide and gather information, to optimize the use of resources, and to optimize efficiency.
• Support identification and qualification of API related impurities and degradants.
• Maintain good laboratory practices and GMP in compliance with safety and environmental requirements.
• Ability to work successfully in both a team/matrix environment as well as independently.
• Performs other related assignments and duties as required and assigned.
• Ensure high quality in analytical work and accurately document all necessary and relevant information in a clear concise manner as per cGMPs.

Experience:

• Proven skills in analytical method analyses of small molecules
• Proven scientific skill and ability to perform complex scientific work independently with little guidance
• Effective in managing multiple competing activities and delivering to timelines
• Ability to work in a cross-function environment
• Working knowledge of laboratory instrumentation
• Facility with learning new software systems
• Experience with NMR, ICP-MS, XRPD, DSC-TGA, LC/MS and/or GC/MS preferred
• Working knowledge of cGLP/cGMP and applicable FDA, EMA and ICH guidance

Education:

• PhD with 2 plus years of experience in pharmaceutical analysis, MS with minimum of 5 years of experience/BS with 8 years of experience.