Senior Scientist, I - Drug Substance Analytical R&D

Responsibilities

• Apply analytical separation and detection modes for complex impurity profiling of pharmaceutical drug substances to further the understanding of emerging non-GMP and 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 substances, intermediates, starting materials, impurities, and impurity profiling.
• Support new product development with advanced method development and validation, 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 research or development program.
• Process, interpret, and visualize data to facilitate project team decisions.
• Communicate and collaborate with cross-functional groups and departments, especially process chemistry, process engineering, and technical operations.
• 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.
• Raises the bar and is never satisfied with the status quo.
• 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

• Bachelors, Masters, or Ph.D. in Analytical Chemistry typically with minimum 10 (BS), 8 (MS), or 0 - 2 (Ph.D.) years related industry experience.
• Strong technical background in chemistry, excellent analytical problem-solving skills.
• Capable of independently developing and troubleshoot analytical methods.
• Demonstrated experience with HPLC analysis and method development preferred along with expertise and fundamental understanding of spectroscopic techniques.
• Comfortable discussing organic chemistry topics within analytical R&D and with partner functions.
• Hands-on experience with synthetic organic chemistry preferred.
• Experience with analysis of peptides and solid-phase peptide synthesis (SPPS) is preferred but not required.
• 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.
• 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.
• Creates a learning environment, open to suggestions and experimentation for improvement.
• Embraces the ideas of others, nurtures innovation and manages innovation to reality.