Senior Scientist
Everett, Washington
Our client, a contract research organization specializing in early phase drug development, is seeking a Senior Scientist to join their team. The incumbent will be assigned to projects based on scientific competency and training. They will ensure the overall integrity/quality of assigned studies. They can also be designated as the main contact for client interactions laboratory for their assigned projects.
Key Responsibilities:
- Could be assigned to assay development, qualification, validation and production expert in multiple assay types and mentor for more junior staff.
- Could have associate scientists and/or scientist I and II reporting to them
- 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
Qualifications:
- 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 2 years experience as Scientist II or equivalent.
- Knowledge of regulatory agency guidelines, must understand general SOPs and have excellent knowledge of GLP regulations.
- Good organizational skill, highly flexible, sense of urgency, excellent troubleshooting skills, client oriented, attentive to details
Thank you in advance for your interest, only individuals deemed to have the skill set and experience to fit the role will be contacted. Applicants must be legally entitled to work in Canada without sponsorship.
Lock Search Group is a National Executive Recruitment firm with 11 offices in Canada and one in the United States, a staff of more than 30 Consultants and Associates, and expertise in 11 major disciplines. Our mission is to provide exceptional Recruitment and Consulting Services to clients and candidates. We apply our experience and expertise to deliver solutions with a personalized approach that focuses on client needs and candidate goals.
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