DEPARTMENT: Pathology
REPORTS TO: Department Director
SUMMARY
Position requires technical knowledge and comprehensive oversight of all ongoing pathology projects for CBSET clients and is key for the development of future CBSET assays/business. Provides oversight for CBSET pathology projects with regards to:
- Content: Review scope and budgets to ensure scopes of work in LOPAs are translated into pathology protocol sections.
- Timelines: Determine and monitor project timelines.
- Processes: Identify project components that require method development or training prior to initiation of work, oversee necessary training sessions.
- Communication: This position requires technical knowledge and comprehensive oversight of all ongoing pathology projects for CBSET clients and client communication is key for the development of future CBSET assays/business.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Project Development:
- Work with Business Development, Medical Writing, Laboratory Supervisor/Manager, SDs and Pathologists to ensure contracts and protocols properly address client scope of work.
- Attend Sponsor calls to enable proper alignment of intended processes into LOPAs/protocols and to discuss technical aspects and how these may affect project implementation.
- Technical Staff training:
- Identify needs in staff training. Assist with implementing training sessions to build capacity/skills in those areas to continue to meet demands and maintain on-time workflows.
- Timelines/ Work prioritization:
- Manage project scheduling and set project priorities across projects.
- Set timelines for pathology aspects of studies including trimming, histology, immunostaining, imaging, and other functions.
- Monitor progress of projects, and deliverables across Pathology and troubleshoot as needed.
- Work with Pathology Quality Control Specialist on timing of data review and archival processes.
- Communicate internally (Path, Med Writing, QA, SDs) and externally (sponsors) re: project scope, timing of deliverables for pathology only projects as well as support Sponsors needs in internal meetings.
- Key interface with:
- Business development on client calls and scopes of work, feasibility and pricing of work and pursuit of novel areas and sponsors.
- Pathology technical staff and scientists: Development of methods, and creating new service opportunities.
- Pathology Lab management: Interface on operations, timelines and deliverables.
- Medical Writing: Project status and updates.
- Study Directors: Status of relevant projects/components.
- Sponsors: Status of timelines, deliverables, and external/ send-in/ pathology-only projects.
QUALIFICATIONS:
- Superlative oral and written communication skills.
- Ability to lead and work effectively as a team member.
- Flexibility and willingness to perform other related duties as required.
- Education:Bachelor’s degree (BS) in science required.
- Experience:> 2 years laboratory experience required. Project coordination and laboratory experience required. Experience in GLPs preferred.
- Certification/Licensure: Driver’s license; HT or HTL (ASCP) certification preferred.
PHYSICAL DEMANDS:
- Must be able to perform laboratory procedures, which require, talking, hearing, standing or sitting for long periods of time, entering data into a computer, using appropriate instruments, reaching with hands and arms, working in narrow spaces, and wearing safety equipment (PPE) according to OSHA regulations and company standards.
WORK ENVIRONMENT:
- Animal facility and laboratories with moderate noise possible anc exposure to potential zoonotic agents, hazardous/noxious devices (e.g., needles, scalpel blades etc.), chemicals (e.g., anesthetic gases, formalin, alcohols, xylenes, etc.), and/or radiation.
- General office working environment with quiet noise conditions.
ADDITIONAL REQUIREMENTS:
- May require occasional duties on weekends and/or holidays.
- May require occasional travel.
All employees are required to satisfactorily perform the essential duties and responsibilities of their position. • The essential duties and responsibilities listed above are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required. • Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this job.
If you are interested in this opportunity please send your CV to jobs@cbset.com.