Senior Scientist I, Analytical Chemistry, Chromatography

Role Summary

The Senior Scientist I will independently design and execute analytical methods to support robust manufacturing processes development for clinical phase and commercial products, working closely with cross-functional teams to advance projects through the development pipeline.

Responsibilities

• Responsible for leading the analytical aspects of a project while working with other functional areas to advance projects through the development pipeline.
• Apply analytical separation and detection modes for complex impurity profiling of pharmaceutical products to further the understanding of emerging cGMP manufacturing processes.
• Utilize understanding of a range of analytical techniques to conduct research and development studies related to small-molecule drug products, active pharmaceutical ingredients, intermediates, starting materials, impurities and impurity profiling.
• Support new product development with advanced methods development and validations, technical transfer packages, and generation of technical data in support regulatory requirements.
• Highly autonomous and productive in performing laboratory research or method development, requiring only minimal direction from or interaction with supervisor.
• Formulate conclusions and design follow-on experiments based on multidisciplinary data.
• May initiate new areas of investigation that are scientifically meaningful, reliable, and can be incorporated directly into a development program.
• Process, interpret, and visualize data to facilitate project team decisions.
• Communicate and collaborate with cross-functional groups and departments.
• Routinely demonstrate scientific initiative and creativity in development activities and maintain a high level of productivity in the lab.
• Responsible for method development, testing procedures, and implementation of analytical control strategies to help the advancement of pipeline candidates.
• Understand and adhere to corporate standards regarding code of conduct, safety, appropriate handling of materials, controlled drug and radioactive compounds, and GxP compliance, where applicable.

Qualifications

• BS or equivalent education with typically 7 or more years of experience or MS or equivalent education with typically 5 or more years of experience.
• Demonstrated ability to independently design, execute and interpret critical experiments to answer scientific questions.
• Demonstrated ability to learn, understand and master new experimental techniques.
• Ability to multitask and work within timelines.
• Demonstrated scientific writing skills and strong verbal communication skills.

Preferred Qualifications

• Strong technical background in analytical chemistry, excellent analytical problem-solving skills. Capable of independently developing and troubleshoot analytical methods.
• Hands on experience with chromatographic (HPLC/GC) analysis and method development along with expertise and fundamental understanding of spectroscopic techniques.
• Self-motivated, hard-working, detail-oriented individual able to work in a fast-paced team environment.
• Experience in the use of computerized data handling systems, data analysis and statistical approaches.
• High-quality written and oral communication skills and ability to interact effectively with interdisciplinary scientists and engineers.