Description: CBSET, Inc. is a recognized leader in preclinical biomedical research. We make it our mission to help our sponsors accelerate the development of novel and innovative pharmaceuticals, biotechnologies, and medical devices. CBSET offers extensive regulatory and scientific expertise to the medtech and biopharma industry around the globe in order to rapidly transform early-stage concepts into novel therapies.
By working at CBSET, you will be part of a collaborative effort with our clients to advance biomedical research through innovative, high-quality services. In addition, CBSET is proud to offer a generous benefits package, which includes health, dental and vision plans, life insurance, short-term and long-term disability, and an opportunity to participate in a 401(k) plan.
BASIC SUMMARY: Provide operational management for CBSET pathology laboratories, staff, facilities, and equipment, including comprehensive oversight of all pathology deliverables for CBSET client work.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Conduct of both staff and project scheduling (macro and micro) including day to day duties and assignments, and all GLP laboratory functions.
- Generation of timelines for all laboratory functions, tasks and deliverables, including projections for slides, reports, data submissions, and archival processes.
- Ongoing assessment and setting of project priorities.
- Oversight of equipment maintenance schedules per GLPs.
- Oversight and development of training modules, staff training records per GLPs.
- Development of operational plans for procurement of pathology equipment and development of novel techniques/methodologies.
- Coordination of intra- and interdepartmental functions:
- Integration of necropsy, histopathology, immunostaining, SEM, and imaging functions within Department of Pathology.
- Communication with:
- Study Directors regarding details internal/CBSET projects;
- Sponsors regarding external/ send-in/ pathology-only projects.
- Contracts team regarding feasibility and pricing of leads
- Business Development regarding pursuit of novel areas and sponsors.
- Supervision, mentoring, and training for technicians in all areas of pathology.
- Ensuring timely and quality generation of data in compliance with GLP guidelines and applicable regulations, with generation of appropriate documentation of deviations and incidents.
- Lead pathology role in review and development of SOPs and study protocols.
- Superlative oral and written communication skills.
- 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. MS or PhD (optional)
Experience: > 5yrs Pathology/ Histopathology laboratory management experience required. >3 yrs management experience required. Specialty skills in development of novel histopathology laboratory methods preferred. Experience in GLPs required.
Certification/Licensure: Driver’s license, HT or HTL (ASCP) certification preferred
- 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
- Specific vision abilities required by this job include close vision, color vision, depth perception, and the ability to adjust focus.
- Animal facility and laboratories with moderate noise possible and exposure to hazardous/noxious devices (e.g., needles, scalpel blades, etc.) and chemicals (e.g., anesthetic gases, formalin, alcohols, xylenes, etc.)
- General office working conditions, with generally quiet noise conditions
- May require occasional duties on weekends and/or holidays.
- May require occasional travel.
Job Type: Full-time
- Regulations: 1 year (Preferred)
- Management: 1 year (Preferred)
- Contracts: 1 year (Preferred)
- Laboratory Management: 1 year (Preferred)
- Driver's License (Preferred)
- Paid time off
- Parental leave
- Health insurance
- Dental insurance
- Healthcare spending or reimbursement accounts such as HSAs or FSAs
- Other types of insurance
- Retirement benefits or accounts
- Education assistance or tuition reimbursement
- Flexible schedules