Senior Scientist I - Analytical Chemistry

About the role

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.

Responsibilities

• 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.

Preferred qualifications

• Advanced degree in Analytical Chemistry.
• Understanding of cGMP and regulatory requirements.
• Practical knowledge of modern peptide manufacturing processes, organic structure, functional groups, chemistry.
• Familiarity with chemical biology fundamentals and related analytical techniques including recombinant protein expression and purification, cell culture, immunoassays, and gels.

Key leadership competencies

• Builds strong relationships with peers and cross functionally with partners outside of team to enable higher performance.
• Demonstrates agility in triaging priorities, pivoting strategy when faced with change, and independently resolving bottlenecks and conflicts.
• Highly developed ability to work as part of a team and an effective communicator.
• Creates a positive learning environment, open to suggestions and experimentation for improvement.
• Embraces the ideas of others, nurtures innovation, and manages innovation to reality.
• Actively supports and instructs less experienced colleagues.
• A quick learner who is highly motivated to drive for results.