Director Bioanalytical Services
Director Bioanalytical Services
Pacific Biomarkers is a specialty biomarker testing laboratory operating under bioanalytical regulations and CAP/CLIA certifications supporting pharmaceutical and biotech companies for preclinical and Phase I-IV studies of drug development. Please refer to www.pacbio.com for further details.
Position: Director Bioanalytical Services
The Director of Bioanalytical Services (DBS) is responsible for organizing and managing the personnel, projects, and activities assigned to the bioanalytical section of the laboratory. The Director implements plans needed to ensure that the available laboratory resources affect superior laboratory analyses in a highly efficient and productive environment. The Director must, in consultation with the Chief Scientific Officer and VP of Laboratory Services, develop bioanalytical procedures to ensure that sound scientific principles form the foundation for laboratory operations. The primary role of the bioanalytical section is to develop, validate, transfer, implement and operationally transition new immunoassays for large molecules added to the Company’s testing services. It is critical that the Director has several years of experience in analytically validating assays used for testing immunogenicity from a biologic drug. This will require assay development expertise and collaborative communication within and across other departments. The Director must have in-depth experience with developing de-novo immunoassays including in-depth assay troubleshooting skills. The Director must participate with the supervisory team in developing the plans used in the laboratory. The Director will also participate in discussions regarding the scientific and strategic direction of the organization. The DBS is required to serve as a resource to the Business Development team supporting client inquiries, leading scientific discussions and providing technical insights.
- Primary responsibility is to provide technical leadership in choosing the best practices for bioanalytical functions of the 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 laboratory to clients, vendors, auditors, investors, news media, and other outside organizations
- Communicates effectively with other PBI 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, GCP, and bioanalytical.
- 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
Knowledge & Skills:
- Provide scientific writing and communication for presentations, reports and scientific publications
- Have in-depth knowledge of the bioanalytical guidelines, CAP, CLIA, and CLSI.
- Have in-depth experience with developing de-novo immunoassays including in-depth 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 communications 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:
- PhD with training in bioanalytical and 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 pharma bioanalytical laboratory environment and/or diagnostic or bioanalytical CRO industries
- Research training, and demonstrated scientific and research expertise, preferably in a specialty complementary to PBI’s areas of expertise
- Financial and personnel administrative competence
Competitive Salary Ten days paid holidays
401k Plan Two weeks paid vacation
Medical, Dental & Vision Plans Casual working environment
Pre-Tax FlexibleSpending Accounts Life Insurance, AD&D
Central Location in Seattle