- Apply analytical separation and detection modes for complex impurity profiling of pharmaceutical products to further the understanding of emerging cGMP manufacturing processes.
- Responsible for leading the analytical aspects of a project while working with other functional areas to advance projects through the development pipeline.
- 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.
- Generate original technical ideas and research or development strategies.
- 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 research or 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 research or 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 drug discovery 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.
- Bachelors, Masters, or Ph.D. in Analytical Chemistry typically with a minimum of 14 (BS), 12 (MS), or 6 (Ph.D.) years related industry experience.
- Strong technical background in analytical chemistry, excellent analytical problem-solving skills. Capable of independently developing and troubleshoot analytical methods.
- Hands on experience with HPLC 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.
- High-quality written and oral communication skills and ability to interact effectively with interdisciplinary scientists and engineers.
- Advanced degree in Analytical Chemistry.
- Understanding of cGMP and regulatory requirements.
- Practical knowledge of organic structure, functional groups, chemistry, and modern spectroscopic techniques as applied to small-molecule analytical analysis.
Key Leadership Competencies:
- Builds strong relationships with peers and cross functionally with partners outside of team to enable higher performance.
- Learns fast, grasps the "essence" and can change course 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.
Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel: Yes, 5 % of the Time
Job Type: Experienced