Senior Scientist I - Analytical Chemistry

Responsibilities

• Responsible for leading the analytical aspects of a project including control strategy development, specification justification, method development and validation, data generation, and regulatory submission contributions.
• Proficiency with the relevant analytical techniques to support development of peptide products including the active pharmaceutical ingredient, 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 to support regulatory requirements.
• Highly autonomous and productive in performing laboratory research or method development independently, requiring only minimal direction from a 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.
• 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 with 10 to 12 (BS), 8 to 10 (MS), or 0 to 4 (Ph.D.) years peptide-related industry experience.
• Strong technical background in analytical chemistry, excellent analytical problem-solving skills. Capable of independently developing and troubleshoot analytical methods.
• Experience in analytical techniques relevant to peptide product development including mass spectrometry, amino acid analysis, advanced separation techniques, and higher-order structure studies.
• Familiarity with forced degradation, impurity tracking, and stability requirements for peptide products
• 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.