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Bio/Pharma Operations Leader

Position Summary

The Director/Manager of Lab Biobanking is responsible for ensuring the overall success of company-wide lab operations including, but not limited to, facilities and equipment, vendor relationships, records and document control, operations management, process management, cost control, quality management, generation and retention of clients, and staff development.

Bio/Pharma Operations Leader

Position Summary

The Director/Manager of Lab Biobanking is responsible for ensuring the overall success of company-wide lab operations including, but not limited to, facilities and equipment, vendor relationships, records and document control, operations management, process management, cost control, quality management, generation and retention of clients, and staff development.

Experience and Requirements

• BA/BS, or combination of education and 10+ years of relevant scientific work experience, supporting biobanking preferred
• Leader who is self-motivated, professional, detail-oriented, with excellent oral and written communication skills who thrives in a fast-paced team environment
• In-depth experience creating procedures, and ensuring quality and compliance
• In-depth knowledge and understanding of laboratory and biorepository operations, lab accreditations (CLIA, CAP), and regulatory compliance
• In-depth understanding of supply chain management and procurement experience
• Ability to work, be on call during off hours and the weekend, and travel, as required
• Computer Skills: MS Word, MS Excel, Internet, MS Outlook, and experience with research informatics and laboratory information management system development for samples/clinical annotation

Position Elements

• Directs and serves as a leader, innovator, coordinator, and change agent in the pursuit of strengthening biobanking operations
• Directs all departmental initiatives, as assigned, related to team development, resource allocation, accountability, communication, and strategy
• Owns the development of the system-wide biorepository operations, including planning, organizing, staffing, influencing, and controlling processes for research participation recruitment, consenting, specimen procurement and accessioning, and clinical annotation
• Owns all service deliverables with a positive attitude and the highest level of honesty and integrity
• Ensures the physical and environmental conditions of the lab are appropriate for operating activities; maintains an organized and accurate physical and electronic inventory of biospecimens, and provides a safe environment in which employees are protected from physical, chemical and biological hazards
• Participates in the development and implementation of operations budget to ensure compliance with organizational expenditure requirements. Oversees and manages the budget and productivity measurements of all biobanking operations
• Guides to ensure compliance with all relevant policies, procedures, guidelines, and all other regulatory and accreditation standards. Ensures safety and risk management are integrated into daily processes and operations at all levels, to include all implemented Policies and Procedures, and accuracy in all outlined Critical Control Points (CCP)
• Guides to ensure innovation remains top of mind for our team, and we continue leading the way in creating and producing outstanding services designed to deliver effective outcomes
• Guides to ensure productivity and quality are at or above expectation for all areas of responsibility

Bachelor’s Degree