Senior Scientist I/II, Analytical Chemistry - Particle and Material Analysis

Role Summary

Senior Scientist I/II in Analytical Chemistry focusing on Particle and Material Analysis within the Physical Analytical Chemistry group of the SPC center. Responsible for applying physical analytical technologies to support drug substance and drug product development, including particle characterization, solid form development, microscopy and imaging, and related techniques. You will design and execute studies, develop test methods when appropriate, and translate results into actionable insights for development programs and regulatory submissions.

Responsibilities

• Utilize understanding of a range of physical analytical chemistry techniques to conduct research and development studies and route cause analysis related to pharmaceutical materials, processes, and products
• 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, method development, problem-solving, 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.

Qualifications

• Bachelors, Masters, or Ph.D. in Chemistry, Material Science, Pharmaceutical Sciences, or related field with minimum10 (BS), 8 (MS), or 0-2 (Ph.D.) years related industry experience.
• Strong technical expertise in particle characterization including Laser Diffraction, Dynamic Light Scattering, Laser Obscuration, and Microscopic imaging (optical, SEM, micro CT, and Flow Imaging)
• Strong technical background in particle characterization, excellent problem-solving skills. Capable of independently developing and troubleshoot analytical methods.
• Experience with thermal (TGA, DSC) and spectroscopic analysis (PXRD, IR, Raman & fluorescence) is preferred
• Experience with post data collection processing, including 3D data reconstruction, artificial intelligence and machine learning strategies is preferred
• Experience with characterizing spray-dried material, peptides, LNPs, LAIs is preferred
• Ability to coordinate activities and work simultaneously on multiple projects, in a global, fast-paced, setting where priorities may change quickly.
• Proven effective written and verbal communication skills and ability to interact effectively with interdisciplinary scientists, engineers, quality staff, regulators, and management.
• High attention to detail and creative problem solving while exhibiting strong interpersonal skills and proven ability to work independently as well as part of teams
• Knowledge of instrument set-up, troubleshooting, management and maintenance.
• Experience extracting insights from multidimensional data sets, along with other physical analytical characterizations, and connecting to pharmaceutical materials, processes, and products
• Practical knowledge of organic structure, functional groups, chemistry, and modern spectroscopic techniques as applied to small-molecule analytical analysis.