Preclinical Research & Laboratory Operations Manager

The Preclinical Research & Laboratory Operations Manager is responsible for the oversight of preclinical research & histopathology laboratory operations across our sites/facilities. This position facilitates strategic and operational planning for sponsored studies and research endeavors. The responsibilities also include coordinating end-to-end study resourcing and timelines, organizing workloads, budgets, quotations, and maintaining and developing Standard Operating Procedures and other Quality Management System (QMS) documents. The Preclinical Research & Laboratory Operations Manager will contribute to the expansion of our preclinical & laboratory operations, including set-up of new facilities, implementation of efficient and scalable processes, and recruitment of highly qualified personnel

Responsibilities

Facilitate strategic and operational planning for new research endeavors, including costing and schedule/timeline estimates.

• Schedule and implement projects
• Liaise with the Financial Manager on budget and expenses
• Prepare proposals/quotations for clients

Write and implement IACUC applications to cover all preclinical studies.

Oversight of preclinical research & histopathology laboratory operations across sites by managing resources, initiatives, and day-to-day operations.

• Responsibility for expansion of laboratory facility, including laboratory design and set-up (including major and minor equipment purchases)
• Plan vivarium space requirements and ensuring capacity across current and future facilities
• Coordinate end-to-end study planning, resourcing, and timelines
• Manage applicable project management/resourcing software
• Organize workloads to meet turnaround time goals
• Coordinate study logistics (including ordering and/or shipment of materials and supplies, as applicable)
• Evaluate productivity and improvements to equipment, processes, and staff
• Work with Study Directors to assure proper documentation and Standard Operating Procedures (SOPs) compliance
• Maintain applicable GLP and 21 CFR Part 11 compliance
• Manage all lab equipment, preventative maintenance, and service contracts with vendors
• Lead infrastructure, capability, and renovation projects, as needed
• Maintain laboratory safety standards and monitor any safety issues
• Participate in personnel decisions related to hiring, such as proactively identifying staffing needs, participating in the recruitment process, and onboarding of new employees
• Ensure staff training in all processes and adherence to SOPs

Quality Assurance

• Adherence to existing and development of new SOPs to maintain and improve the Biospective’s QMS
• Active coordination with Quality Assurance Unit (QAU)
• Assist the QAU and Laboratory Quality Assurance (QA) Lead to:
  • Review and maintain Preclinical, Laboratory, and Equipment SOPs, ensuring the quality of preclinical and laboratory studies
  • Conduct and/or support internal audits for laboratory and pre-clinical studies; issue findings and compliance reports
  • Track non-compliance activities for laboratory and pre-clinical studies