Bioanalytical Scientist

Position Details:

• 100% onsite M-F in Aliso Viejo, CA
• Type: 12 month contract with opportunity for permanent conversion

Position Summary:

Motivated bioanalytical scientist to join the Pharmacokinetics, Drug Disposition, and Clinical Pharmacology team. This team develops and executes the nonclinical and clinical ADME strategies for our novel pharmaceutical products. The team is also responsible for developing and performing immunoassay and liquid chromatography-tandem mass spectrometry (LC-MS/MS) assays to assess local biodistribution, systemic exposure, and quantitation of small molecules, biologics and their metabolites in biological fluids and tissues. A successful candidate will be a LC-MS/MS scientist focusing on small molecules, contributing to internal, non-regulated (non-GLP) method development and quantitation efforts to provide timely bioanalytical support for Research and Development project teams. The successful candidate will demonstrate excellent collaboration and communication skills and will be versatile, self-motivated, timeline and process oriented.

Responsibilities:

• Perform hands on LC-MS/MS method development, method optimization, troubleshooting, fit-for-purpose qualification and non-regulated bioanalytical sample analysis in a variety of biological fluids and tissues in a timely manner
• Maintain timely and accurate laboratory records consistent with good documentation practices
• Write formal study reports and bioanalytical sections of regulatory documents for submission to regulatory agencies.
• Maintain state-of-the-art lab equipment (e.g. LC-MS/MS instruments)
• Closely collaborate with colleagues in the non-clinical development organization and other relevant departments

Requirements:

• Bachelor’s degree in chemistry or a closely related discipline with 3 years of relevant experience OR
• Master’s degree with 2 years of experience
• Hands-on experience with development and non-regulated qualification of LC-MS/MS bioanalytical methods for small molecule drugs and peptides using various techniques (protein precipitation, LLE and SPE ) in biological fluids and tissues
• Strong experience with small molecule analysis in biological samples
• Hands-on experience with sample preparation techniques including protein precipitation, LLE, and SPE
• Experience working with animal plasma and tissue samples (rats, rabbits, monkeys, mini pigs) preferred
• Large molecule experience is a plus but not required
• Proven independence and problem-solving ability as it relates to LC-MS/MS assay development
• Strong verbal and written communication skills.
• Strong organizational skills and keen attention to detail; ability to handle multiple projects in a fast-paced environment
• Willingness to learn and adapt to new techniques and technologies. A collaborative mindset, with the ability to work effectively as part of a team.