Preclinical Research & Laboratory Operations Manager

Website Biospective

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


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

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