Work Location: Orange County, California

Summary:

This position seeks a motivated scientist to support bioanalytical method development and quantitation for research and development projects, focusing on small molecules using LC-MS/MS. The role involves hands-on laboratory work, collaboration with cross-functional teams, and preparation of documentation for regulatory submissions.

Responsibilities:

• Develop, optimize, and troubleshoot LC-MS/MS methods for small molecule analysis in various biological matrices.
• Conduct non-regulated bioanalytical sample analysis and fit-for-purpose method qualification in a timely manner.
• Maintain accurate and timely laboratory records in accordance with good documentation practices.
• Prepare formal study reports and contribute to bioanalytical sections of regulatory documents.
• Ensure proper maintenance and operation of laboratory equipment, including LC-MS/MS instruments.
• Collaborate closely with colleagues in non-clinical development and other relevant departments to support project goals.
• Apply problem-solving skills and demonstrate independence in assay development and troubleshooting.
• Adapt to new techniques and technologies while managing multiple projects in a fast-paced environment.

Qualifications:

• Bachelor’s degree in chemistry or a closely related discipline with 3-6 years of relevant experience, or Master’s degree with 2+ years of experience.
• Hands-on experience with LC-MS/MS bioanalytical method development and non-regulated qualification for small molecule drugs and peptides.
• Proficiency in sample preparation techniques such as protein precipitation, liquid-liquid extraction (LLE), and solid-phase extraction (SPE) in biological fluids and tissues.
• Demonstrated independence and problem-solving ability in LC-MS/MS assay development.
• Strong verbal and written communication skills.
• Excellent organizational skills and attention to detail, with the ability to manage multiple projects simultaneously.
• Willingness to learn and adapt to new laboratory techniques and technologies.
• Collaborative mindset and ability to work effectively as part of a team.

Published Category: Analytical & Process Development