Job Description

The Product Development Science and Technology (PDS&T) Analytical group is currently seeking a Senior Scientist I to join our team. As a Senior Scientist I, you will have the opportunity to independently design and execute analytical methods to support robust manufacturing processes development for clinical phase and commercial products. You will play a crucial role in ensuring the quality and efficacy of our products, making a direct impact on patient health and well-being. This position involves highly collaborative work where you will have the chance to work closely with cross-functional teams including process and product development, CMC, process engineering, internal and external manufacturing, quality assurance, supply chain, and Operations Manufacturing Sites. This collaborative environment will allow you to expand your knowledge and skills while making meaningful contributions to our organization. Further you will be a part of the effort to build automated analytical workflows and deriving insights from large data sets deploying advanced statistical approaches aligned with our fit for the future principles.

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.

Develop and leverage automated/real-time analysis approach as alternative to manual approaches and apply novel data analysis to large data sets to derive insights to support Lab/Factory of the Future effort

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.