LCMS Principal Scientist
Actalent is seeking a Principal Research Scientist to serve as the primary scientific expert for pre-clinical GLP bioanalytical method development, validation, and sample analysis using triple quadrupole LC-MS/MS systems. This role focuses on both small and large molecule analysis, including ADCs and complex large molecule LC-MS/MS assays and sample preparation.
About the role
The scientist provides direct technical leadership, collaborates closely with clients and internal teams, ensures strict adherence to GLP and regulatory guidelines, and delivers high-quality scientific reports in a fast-paced, collaborative environment. The role offers a balanced mix of laboratory and client-facing responsibilities, with approximately 50% of the time spent at the bench performing LC-MS/MS method development, validation, and sample analysis, and 50% devoted to client interaction and method development planning activities.
You will work in a GLP-regulated laboratory environment that supports pre-clinical bioanalytical studies, using advanced LC-MS/MS platforms such as Shimadzu and SCIEX systems and leveraging Watson software for data and study management. The setting emphasizes quality, compliance, and scientific rigor, with close collaboration between scientists, analysts, and regulatory and quality teams.
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.
- Act 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.
- Support multiple concurrent projects by effectively prioritizing tasks and meeting established deadlines.
- 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.
- 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.
Pay
The pay range for this position is $120,000.00 - $150,000.00 per year. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.
Benefits
- Health, Dental, and Vision Insurance Plans
- 401(k)/RRSP with Employer Match
- Paid Vacation and Holidays
- Paid Sick and Bereavement Leave
- Employee Assistance & Telehealth Programs
- Telework when applicable
Schedule
This is a permanent, fully onsite position based in Everett, WA.