Scientist I, Analytical Chemistry

About the Role

The Product Development Science and Technology (PDS&T) Analytical group is currently seeking a Scientist I to independently design and execute analytical methods to support robust manufacturing processes development for clinical phase and commercial products. This role involves highly collaborative work with cross-functional teams including process and product development, CMC, process engineering, internal and external manufacturing, quality assurance, supply chain, and Operations Manufacturing Sites.

Responsibilities

• Independently design, execute and interpret critical experiments to answer scientific questions.
• Understand the broad objectives of the project as well as their role in achieving those objectives, and modify experimental plan when required to respond.
• Learn, understand and master new experimental techniques, and act as a resource or mentor for others.
• 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.
• Improve test methods for marketed products and perform investigations.
• 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 5 or more years of experience or MS or equivalent education with typically 2 or more years of experience.
• Understanding of cGMP and current regulatory requirements.
• Strong technical background in analytical chemistry, excellent analytical problem-solving skills. Capable of independently developing and troubleshoot analytical methods.
• Demonstrated ability to independently design, execute and interpret critical experiments to answer scientific questions.
• Demonstrated ability to learn, understand and master new experimental techniques.
• Hands on experience with HPLC analysis and method development along with expertise and fundamental understanding of spectroscopic techniques.
• Experience in the use of computerized data handling systems, data analysis and statistical approaches.
• Ability to multitask and work within timelines.
• Self-motivated, hard-working, detail-oriented individual able to work in a fast-paced team environment.
• High-quality written and oral communication skills and ability to interact effectively with interdisciplinary scientists and engineers.

Key Leadership Competencies

• Builds strong relationships with peers and cross functionally with partners outside of team to enable higher performance.
• Learns fast, grasping the "essence" and can change courses quickly where indicated.
• Raises the bar and is never satisfied with the status quo.
• Creates a learning environment, open to suggestions and experimentation for improvement.
• Embraces the ideas of others, nurtures innovation and manages innovation to reality.