Pacific Biomarkers provides comprehensive laboratory support for pharmaceutical and diagnostic product research. We specialize in standardized, high quality efficacy and safety testing for clinical research in lipids and cardiovascular risk, diabetes and metabolic syndrome, osteoporosis, bone and cartilage metabolism, and related areas.
This position requires expanded ability to perform and/or develop bioanalytical immunoassay methods and design research methods and testing procedures on a variety of different platforms, troubleshoot assay performance problems, and draft validation reports with minimal supervision and guidance. More specifically, experience with biomarkers developed and validated from ELISA kits or proprietary reagents for pharmacokinetic and anti-drug antibody (immunogenicity) assays is required. Understanding Good Laboratory Practice and how it is applied to above services is required. Master’s degree in a physical science or at least eight years of ‘bench’ laboratory experience in a clinical or GLP laboratory is required.
Essential Duties and Responsibilities
Organizes and documents scientific projects and activities. Monitors new assay validation/development progress and client assay validation reports and communications.
Performs and provides direction for establishing, designing, and validating new tests in response to the needs of clients. Provides support to technical staff in executing assay validation experiments and documentation of data in reports.
Prepares advanced data analysis, merging and transforming files and data, and identification of outliers for further study. Independently performs statistical tests as required for the assigned project, to study outliers, or to answer questions.
Prepares validation reports that meet standards of written scientific standards and comply with quality assurance and operations standards and the client-specific requirements. Documents testing and bench work steps.
Writes and reviews assay methods, validation plans, validation and qualification reports, assay checklists, and SOPs.
Reviews validation and clinical testing data and ensures timely reporting of test results.
Manage and monitor critical reagent/QC inventory and expiration and ensure timely transition of new reagents.
Participates in preparing subject matter briefings and position papers on clinical diagnosis testing, validation, and data integrity.
Serves as a resource to business development, in-service education, and for troubleshooting logistic and technical issues with tests and equipment.
Work with Project Management and Data Management departments to ensure that all test codes and technical protocols are correctly assigned for all clinical studies.
Coordinates with internal and external customers to integrate services and data into new and ongoing tests.
Provides leadership/mentoring/training over Research Associates and technical staff.
Serves as back-up to the laboratory in routine testing as designated.
Relays information in a timely manner to supervisory personnel regarding problems that may impact the laboratory’s ability to meet expected service and turn-around-time.
Performs other duties related to laboratory performance and efficiency as assigned to support the overall objective of the position.
Works on assignments that are complex in nature where considerable judgment and initiative are required in resolving problems and making recommendations.
Knowledge and Skills
The position requires advanced specialized knowledge of theories and principles of analytical biomechanical and protein chemistry techniques, such as but not limited to, immunoassays for bioanalytical immunogenicity testing for large molecules and pharmacokinetic markers. Requires advanced knowledge of database designs, physical structures and relationships, data entry, retrieval, and conversion techniques. Requires well-developed skills using office productivity applications such as spreadsheets, data reduction and statistical applications, and presentation graphics. Requires advanced math skills to conduct tests and analyze the significance of clinical tests and statistical data. Requires additional knowledge of statistical methods, including computer-aided statistical software. Requires well-developed human relations skills to convey scientific concepts and consult with a range of internal and external contacts in formal settings for purposes of testing, conversion of data, and problem solving.
Requires ability to perform the functions of the position, including planning, testing, and reporting. Requires ability to analyze and interpret biomechanical and protein chemistry test data. Requires ability to think independently and resolve complex problems without supervision or guidance. Must know how to operate the computers, operating systems, peripherals, and other equipment used by the Company for information retrieval, storage, analysis, and processing. Requires the ability to write query instructions to access information from databases and libraries. Requires the ability work collaboratively, follow logical progressions of testing projects and to think logically, creatively, and in abstract terms. Requires the ability to employ critical thinking and evaluation techniques when developing and testing significance of scientific and research-oriented data. Requires the ability to analyze and solve technical problems under time pressure. Requires the ability to read, interpret and apply complex technical information.
Internal Number: 0012018
About Pacific Biomarkers
Pacific Biomarkers (PBI) provides comprehensive laboratory support for pharmaceutical and diagnostic product research in key focus areas including: cardiovascular risk, diabetes and metabolic syndrome, osteoporosis, bone and cartilage metabolism. The selected candidate will be a motivated problem-solver with good organization, communication and documentation skills. Employment Package: Competitive Salary 10 paid holidays 401k PlanMedical, Dental & Vision Plans Casual working environmentLife Insurance, AD&D Pre-Tax Flexible Spending AccountsTwo weeks paid vacation Central Location in Seattle