Scientist

Responsibilities

• Provide technical and scientific expertise for small and large molecule analysis using LC-MS/MS, with a primary focus on method development and method validation.
• Serve as the industry expert for pre-clinical GLP bioanalytical study method development, validation, and sample analysis utilizing triple quadrupole LC-MS systems.
• Serve as the subject matter expert for ADCs and large molecule LC-MS/MS analytical assays and associated sample preparation workflows.
• Serve as principal investigator or contributing scientist for LC-MS/MS studies, ensuring scientific integrity and regulatory compliance.
• Ensure all work operates in full compliance with GLP requirements, study protocols, and standard operating procedures (SOPs).
• Maintain open, direct communication with clients, including attending recurring calls and providing scientific updates as needed.
• Prepare all necessary study and laboratory documentation required to support in-lab analysis.
• Complete and deliver high-quality scientific reports to clients on time, clearly summarizing methods, results, and conclusions.
• Prepare biological materials, including animal blood and tissues, for analytical assays to be run on LC-MS/MS instrumentation.
• Maintain and document chain of custody for specimens, reagents, controls, and samples in the laboratory to ensure data integrity.
• Perform analytical assays according to protocol or other guiding documents, ensuring accurate, complete, and contemporaneous documentation.
• Maintain and update facility records related to laboratory operations and analytical activities.
• Review laboratory records, procedures, and study data for completeness, accuracy, and compliance with GLP and internal standards.
• Assist with calibration, optimization, maintenance, and data collection for analytical instruments, including LC-MS/MS systems.
• Perform routine laboratory maintenance, such as cleaning, stocking supplies, and completing equipment maintenance tasks.
• Document deviations from laboratory procedures and study protocols in a timely manner and contribute to the development and implementation of corrective actions.
• Collaborate with internal regulatory and quality departments to ensure robust quality and compliance oversight of GLP SOPs.
• Ensure compliance with GLP, FDA ICH M10 guidelines, ALCOA+ principles, USDA, and AAALAC guidelines, and identify opportunities for process and quality improvement.
• Contribute to a collaborative, values-driven culture focused on employee development, customer focus, quality and excellence, respect, and integrity.

Requirements

• Bachelor’s degree in Immunology, Biology, Chemistry, or another closely related scientific discipline.
• Minimum of 5 years of relevant GLP laboratory experience.
• Ideal minimum of 5 years of experience as a Research Scientist or equivalent in a GLP environment supporting LC-MS/MS work.
• Experience working in a Good Laboratory Practices (GLP) environment.
• Experience working in a contract research organization (CRO) environment or in a bio/pharmaceutical setting supporting method development and validation (minimum of 2 years).
• Strong hands-on experience with LC-MS/MS instrumentation and associated software.
• Experience with triple quadrupole LC-MS systems for bioanalytical method development, validation, and sample analysis.
• Experience with Shimadzu LC-MS systems.
• Experience with SCIEX LC-MS/MS instrumentation.
• Experience using Watson laboratory or bioanalytical data management software.
• Demonstrated ability to handle multiple projects simultaneously, prioritize work effectively, and meet deadlines.
• Proven ability to work in accordance with GLP requirements, protocols, and SOPs.
• Strong documentation skills with a focus on completeness, accuracy, and data integrity (ALCOA+ principles).
• Ability to communicate clearly and professionally with clients and internal stakeholders, both verbally and in writing.

Qualifications

• Master’s degree or PhD in a scientific discipline such as Immunology, Biology, Chemistry, or a related field.
• Extensive experience in method development and method validation for small and large molecule LC-MS/MS assays.
• Expertise in analytical assay design and sample preparation for ADCs and other large molecule therapeutics.
• Experience preparing and handling animal blood and tissues for bioanalytical assays.
• Familiarity with regulatory expectations and guidelines, including FDA ICH M10, USDA, and AAALAC requirements.
• Experience contributing to or leading GLP SOP development, review, and continuous improvement initiatives.
• Strong problem-solving skills and the ability to identify and implement process improvements in a regulated laboratory environment.
• Experience documenting deviations and supporting corrective and preventive action (CAPA) activities.
• Comfort working in a client-facing role, including participation in recurring calls and scientific discussions.
• Motivation to work in a mission-driven environment focused on the discovery, development, and manufacturing support of new drug therapies.