LC-MS Method Development Scientist

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The Scientist, LCMS is assigned to projects based on scientific competency and training. The Scientist will ensure the overall integrity/quality of assigned studies. The Scientist can also be designated as the main contact for client interactions laboratory for their assigned projects.

• Autonomous and proficient developing, planning, managing, conducting, reporting and troubleshooting multiple assay types to ensure scientific quality, regulatory expectations, and client satisfaction
• Assigned by management on studies and tasks based on scientific competency and training (can include method development, validation or sample analysis projects).
• For validations and sample analysis the Scientist can be assigned as Bioanalytical Principal Investigator and is the first point of contact for PM and/or clients for laboratory services and will manage and conduct method development, qualification , validation and production studies for clinical and non-clinical studies in compliance with the protocol/study plan, amendments, GCP, GLPs, SOPs and Best Practices;
• Manage project and order appropriate material, as needed
• When applicable, provide QC support on studies assigned to other team members in laboratory based on training and competencies.
• When applicable, perform data batch review, perform multi-batch trend analysis, complete documentation as required by tracking deviations, events and reports of non-compliance and review or approved Memo to File or SOP/Protocol/Study Plan deviations;
• When applicable, provide a report and/or reporting of results, within study timelines and ensure any deviations/exception events are reflected as appropriate and assure that all analysis conducted is reported and is accurate;
• Manage as to maintain timeline and scheduling commitments
• When applicable review and provide comments and recommendations, as needed, for the bioanalytical portions of preclinical and clinical protocols, study plans, laboratory manuals, Data Transfer Agreements, and/or other document, as needed;
• Support and mentor Analysts in the daily operations for completion of sample analysis and/or validation studies and the analysts work;
• Support and mentor other team members based on expertise,
• Responsible for troubleshooting issues within the studies and be able to resolve them independently via development of appropriate procedure.
• Organize and communicate complex data sets in a clear and concise manner to key stakeholders from diverse backgrounds
• To write, review and updated method SOP as needed
• Participate in meetings with clients, conferences and scientific outreach
• Conduct applicable work in compliance with applicable SOPs, GCPs, GLPs, and observe all company guidelines and policies
• Respecting Health and Safety standards in terms of personal protection, laboratory maintenance, and work procedures;

• Ideally College degree and/or University degree in Chemistry, Biochemistry, Immunology or applicable field.
• Preferred experience in regulated clinical and/or preclinical studies with typically 3 years of experience.
• Minimal 1 year experience as Scientist or…