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 Laboratory Services is a senior management position and is expected to contribute to the change or development of the Company’s strategic and tactical plans. The Director demonstrates the ability to implement these plans by integrating the services provided by the laboratory and other departments, and by providing leadership in maintaining quality, efficiency, and regulatory compliance. This position requires the candidate to be Board certified in laboratory Clinical Science (e.g. ABCC), and attain or retain CLIA/CAP certification as a Laboratory Director. The Director must possess the ability to work with and support business development professionals and provide leadership in growing new business opportunities and focus areas that are aligned with overall Company strategy. The Director works directly with Client and Information Services to accurately communicate and report clinical, scientific and technical information, as wells as laboratory data to customers.
- Establishes standards of performance and quality for supervisors, professional, technical, and support staff. Evaluates staff performance and training needs, and participates in the development of training programs.
- Ensures that laboratory-operating procedures comply with best practice, PacBio quality standards, and regulatory requirements.
- Reviews and responds to quality assurance reports, including protocol deviations, trends in data, and other occurrences identified through QA reviews. Provides advanced subject-matter representation of PacBio at professional conferences, and meetings, and during visits to or by clients, vendors, auditors, investors, and other external organizations.
- Participates in consulting with clients.
- Identifies, researches and details tactics that expand and deepen the Company’s capability and exposure with new focus areas. Identifies and, when appropriate, incorporates emerging technical advances into Company systems.
Knowledge and Skills
Requires the background to attain or retain CLIA/CAP certification as a Laboratory Director. Requires advanced knowledge of the setup and operation of CLIA and GXP regulated laboratories in order to meet or exceed regulations, quality standards, and best practices for efficiency, excellence and profitability. The position requires authoritative and broad knowledge in biomedical science and specific expertise in areas such as diagnostic science, pharmaceutical and biopharmaceutical drug development process, cell biology, and biomarker development,. Experience in research or drug development in therapeutic areas such as diabetes, obesity and metabolic syndrome, lipids and atherosclerosis, arthritis and autoimmune disease, bone metabolism, oncology, or immune function is desirable. Requires knowledge of CLIA, CAP, GXP and other regulatory requirements to which the Company must comply. Requires advanced language skills for reading, and understanding scientific and professional literature, research, and scientific instructions, and for composing reports, publications, marketing literature, applications for grants and licenses, and so forth.
Education and Experience:
The position requires a MD and/or PhD in a field of biomedical science, such as pathology, pharmacology, biochemistry or cell and molecular biology, with additional graduate or post-graduate training in clinical chemistry and five years of progressive post-graduate experience in a clinical trials/research environment (may be acquired through working in the drug-development). Two years or more in a leadership position are desired.
Licenses and Certificates:
Professional Board certification in laboratory Clinical Science (e.g. ABCC).
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
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 possess good communication skills and be able to work effectively in a team
- Must be extremely detail oriented and well organized and be committed to maintaining rigorous documentation standards
- College degree in a scientific/technical field such as information technology, science or mathematics/statistics
- 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 PB 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
We currently have no other open positions.