Pacific Biomarkers is a biomarker and bioanalytical testing services provider, supporting pharmaceutical and biotech companies through Phase I-IV clinical trials of drug development.
We are seeking a highly motivated Research Associate II/III with experience in bioanalytical immunoassays. The position requires excellent ability to validate and/or develop bioanalytical immunoassay methods, 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.
Experience with biomarkers, pharmacokinetic and/or anti-drug antibody (immunogenicity) assays is required. Understanding Good Laboratory Practice and how it is applied to above services is required. Bachelor or Master’s degree in biology/immunology or related field with at least 4-6 years of ‘bench’ laboratory experience in a clinical or GLP laboratory is desired.
Essential Duties and Responsibilities
- Organizes and documents scientific projects and activities. Monitors new assay validation/development progress and client assay validation reports and communications.
- 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.
- Coordinates with internal and external customers to integrate services and data into new and ongoing tests.
- Opportunity to provide mentoring/training over junior 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 good knowledge of theories and principles of biology/immunology and protein chemistry techniques, such as but not limited to, immunoassays for bioanalytical immunogenicity and pharmacokinetic testing for large molecules.
- Requires well-developed skills using office productivity applications such as spreadsheets, data reduction and statistical applications, and presentation graphics.
- Requires well-developed human relations skills to understand scientific concepts and/or consult with senior colleagues for purposes of problem solving.
- Requires the ability to analyze and solve technical problems under time pressure. Requires the ability to read, interpret and apply complex technical information.
- Must be detail oriented, well organized and committed to mastering rigorous documentation standards related to GLP and GCP standards.