Scientist II, Analytical Chemistry

The Product Development Science and Technology (PDS&T) Analytical group is currently seeking Scientist II to join our team. As a Scientist II, 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 patients’ 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.

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.

• 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.
• 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. 

Preferred:

• A degree in Analytical/Physical Chemistry or Biochemistry.
• Practical knowledge of organic structure, functional groups, chemistry, and modern spectroscopic techniques as applied to small-molecule analytical analysis.
• Experience on lab automation is a plus.
• Experience working with contract labs or external suppliers is a plus.
• Experience in performing lab investigations is a plus.

Key Leadership Competencies:

• Build strong relationships with peers and cross functionally with partners outside of team to enable higher performance.
• Learn fast, grasp 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.