As an LC-MS Principal Research Scientist, you will serve as an industry expert for pre-clinical GLP bioanalytical study method development, validation, sample analysis utilizing triple quadrupole LC-MS systems. You will serve as the expert for ADCs and large molecule LC-MS/MS analytical assays and sample preparation. Responsible for direct interaction with clients, report writing, and adherence to regulatory guidelines.
You will collaborate with other scientists, analysts, and departments in a team-oriented environment. You will possess knowledge and experience in a Good Laboratory Practice (GLP) environment and be able to adhere to GLP guidelines and practices.
- Provide technical and scientific expertise for small and large molecule analysis via LC-MS/MS.
- Ensure all work is operating in full compliance to GLP requirements, protocols, and SOPs.
- Maintain open and direct communication and attend recurring calls with clients as needed.
- Serve as principal investigator or contributing scientist for LC-MS/MS studies.
- Prepare all necessary driving documents for in-lab analysis.
- Complete and deliver scientific reports to clients on time.
- Prepare 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.
- Perform the assays according to protocol or other guiding documents with accurate documentation.
- Maintain and update facility records related to the laboratory and its analyses.
- Review laboratory records, procedures, and study data for completeness and accuracy.
- Assist in calibration, optimization, maintenance, and collection of data from analytical instruments.
- Perform routine laboratory maintenance (including cleaning, stocking supplies, equipment maintenance tasks, etc.).
- Document deviations to laboratory procedures and study protocols in a timely manner and provide input for corrective actions.
- Collaborate with internal regulatory departments to ensure quality and compliance oversight on GLP studies.
- Follow Altasciences' Standard Operating Procedures (SOPs), ensure compliance with GLP, FDA's ICH M10 guidelines, ALCOA+, USDA, and AAALAC guidelines, and can identify areas for improvement.
- Bachelor’s degree in Immunology/Biology/Chemistry or other scientific related discipline plus a minimum of 5 years of relevant GLP laboratory experience.
- Experience in a Good Laboratory Practices (GLP) and CRO environment.
- Ability to handle multiple projects, prioritize work, and meet deadlines.
- Ideally a minimum of 5 years as Senior Research Scientist or equivalent in a GLP environment.
The pay range estimated for this position is $110,000 - $120,000 annually. Please note that hourly rates/salaries vary within the range based on factors including, but not limited to, prior relevant experience, skills, education, certification, location as well as internal equity and market data.