If you are interested in working in a dynamic biotechnology environment that is challenging, rewarding and a source of personal pride and growth, we're interested in hearing from you! Pacific Biomarkers is located in Seattle, surrounded by mountains, forests and waterways of the Pacific Northwest.
- Competitive Salary
- Medical, Dental & Vision Plans
- Life Insurance, AD&D
- Two weeks paid vacation
- Ten days paid holidays
- STD (Short Term Disability) benefits
- Casual working environment
- Pre-Tax Flexible Spending Accounts
- 401k Plan
- Central Location in Seattle
645 Elliott Ave W, Suite 300
Seattle, WA 98119
OR e-mail resume to:
Accepting Resumes For The Following Positions:
The Director of Research & Development (DRD) is responsible for organizing and managing the personnel, projects, and activities assigned to the R&D section of the laboratory. The DRD implements plans needed to ensure that the available R&D laboratory resources affect superior laboratory analyses in a highly efficient and productive environment. The DRD must, in consultation with the Chief Scientific Officer, develop procedures to ensure that sound scientific principles form the foundation for laboratory operations, and in consultation with the QA Manager, provide leadership in meeting established quality goals and regulatory standards. The primary role of the R&D section is to develop, validate, transfer, implement and operationally transition new tests added to the Company's test menu. This will involve a great deal of assay development expertise and collaborative communication within and across other departments. The DRD must have in-depth experience with developing de-novo immunoassays including high-level assay troubleshooting skills. The DRD must participate with the supervisory team in developing the plans used in the R&D laboratory section. The DRD will also participate in discussions regarding the scientific and strategic direction of the organization. At times sample testing may be required to be performed by R&D for specific clients. The DRD is required to serve as a resource to the Business Development group supporting client inquiries, leading scientific discussions and providing technical insights.
- Primary responsibility is to provide leadership in choosing the best practices in the R&D laboratory
- Maintain a reliable assay validation tracking system based on the most updated information on contracts and anticipated work
- Regularly review all laboratory-operating procedures, direct and approve updates, and/or delegate this task as appropriate
- Positively represent the Pacific Biomarkers laboratory to clients, vendors, auditors, investors, news media, and other outside organizations
- Communicates effectively with other Pacific Biomarkers executives, managers and lab staff to facilitate the successful performance of laboratory work in accordance with the policies and procedures of the organization
- Review and respond to relevant quality assurance reports, including protocol and procedural deviations, CAPAs, audit findings and trends in QC data that are identified
- Remain informed and current with regulatory guidelines associated with: CAP, CLIA, New York State, CLSI, GLP and GCP
- Ensures that R&D employees are provided proper resources to maintain current competencies as well as ongoing training to comply with regulatory requirements
- Provide direction for changes needed to reduce laboratory production costs
- Assist business development staff by creating technical presentations for sales & marketing
- Contact potential clients at the request of the Business Development department
- Serve as Study Director as described in 21 CFR Part 58 section 58.33
- Observe all Pacific Biomarkers health and safety rules and apply the principles of accident prevention to day-to-day activities
Knowledge & Skills
- Provide scientific writing and communication for presentations, reports and scientific publications
- Have in-depth knowledge of the CAP, CLIA, CLSI and bioanalytical guidelines
- Have in-depth experience with developing de-novo immunoassays including high level troubleshooting skills
- Write, assist in writing, or approve laboratory documents, including standard operating procedures and forms
- Be familiar with developments in laboratory technology and request new or updated instruments when appropriate and aligned with overall Company strategy
- Provide scientific writing and communication skills for presentations, reports and scientific publications
- Ability to build high-performing multicultural teams
- Ability to foster strong relationships with strategic partners, collaborators, internal cross-functional teams, and scientific advisors
Education and Experience
- MD and/or PhD with training in clinical laboratory science
- Professional certification in clinical laboratory science desired
- Broad knowledge of health and clinical sciences with several years experience in similar industry
- Experience in diagnostic laboratory environment and/or diagnostic or CRO industries
- Research training, and demonstrated scientific and research expertise, preferably in a specialty complementary to Pacific Biomarkers' areas of expertise
- Financial and personnel administrative competence
Experience and Qualifications
- Must have professional experience working as a Project Manager for at least six years, preferably with clinical trial operations
- Must possess good written and interpersonal communication skills and be able to work effectively in a team
- Must be extremely detail oriented, well organized and committed to maintaining rigorous documentation standards
- Experience with Microsoft Office (especially Word, Powerpoint and Excel)
- Previous experience in a clinical or research laboratory and familiarity with Laboratory Information Systems a plus
- Lead or supervisory experience desirable
- Bachelor’s degree required; life or medical sciences preferred
- Certification in project management and clinical trials desirable
- Responsible for the successful conduct of assigned projects including the on time provision of client deliverables
- Communicate the needs of the client or study to the appropriate PacBio department and serve as liaison between client and PacBio
- Prepare study plans, central lab materials and documents, and sample analysis reports
- Project and monitor study revenue and other study metrics
- Working with client's data management staff to document clients' specifications for electronic data transmission that include file formats, frequency, and methods. Serve as the liaison between client's data management staff and Pacific Biomarkers programming staff during the development process.
- Set up of Laboratory Information System database fields and tables required for the production of client data files.
- Performing in-house and client-based testing of data export programs to ensure conformance to specifications.
- Transmitting results per data management plan/schedule for each study (includes file creation, review, transmission and associated documentation).
- Facilitating study closeout by communicating sponsor data deadlines to appropriate project management and operations staff.
- Processing electronic manifests for incoming referral samples.
- Developing and maintaining documentation and data management guidelines.
- College degree in a scientific/technical field such as information technology, science or mathematics/statistics.
Experience and Qualifications
- Three or more years of experience in Clinical Data Management required.
- Experience with Microsoft Office products (especially Excel) required.
- Experience with Excel graphs and functions required.
- Experience with relational database concepts including queries required.
- Some programming experience helpful.
- Familiarity with Laboratory Information Systems or other scientific applications a plus.
- Must be extremely detail oriented and well organized and be committed to maintaining rigorous documentation standards.
Experience and Qualifications
- Prefer minimum of two years research or clinical laboratory experience with biochemistry techniques; extensive ELISA experience: two years experience with high volume testing with emphasis on autochemistry analyzers.
- Experience with troubleshooting and editing multipoint nonlinear calibration curves. Excellent pipeting technique under high volume conditions is essential.
- Experience with assays optimization and validation is desired.
- Familiar with Microsoft Office products, Excel and Word.
- Possess good communication and writing skills and able to work effectively in a team when performing assays.
- Must be detail oriented, well organized and committed to mastering rigorous documentation standards related to GLP standards and pharmaceutical clinical trials.
- Must have excellent multitasking skills due to the complexity and variety of projects ongoing in each department.
- Minimum Bachelor’s degree in medical technology, Chemistry, Biology or related science. At least 2 years of experience in a clinical or bio-analytical laboratory setting preferred.
Perform immunogenicity or clinical chemistry testing in a reference laboratory that provides testing support to clinical trials. Testing methods utilized are complex, problematic and produced in high volume. The procedural steps are performed by a team in a fast paced environment and documented using GLP practices. Results are reported through an LIS designed for clinical trials. Excellent multi-tasking skills are required to cope with the execution of multiple test methods simultaneously.
Responsible for processing samples/specimens. Includes specimen centrifugation, preparation of aliquots, logging in samples to the Laboratory Information System (LIS) for laboratory analysis and the proper and safe storage of samples before and after analysis. Requires knowledge of and use of the laboratory information system and sample types used for tests performed in the laboratory. Duties include receiving, accessioning, and processing samples for analysis, storage or send-out and the appropriate documentation of such; becoming familiar with and following procedure for the pulling and refiling of frozen specimens; learning the specific details of specimen processing for pharmaceutical studies, diagnostic studies, and other work in which Pacific Biomarkers, Inc. participates
- Bachelor's degree in Biological or Physical science preferred, High School Diploma or equivalent with some technical training required
- Experience in a medical laboratory preferred
- General computer experience required
- Familiarity with general procedures involved in clinical trial management preferred
We currently have no other open positions.