Senior Director of Bioanalytical Laboratory Operations

1 week ago

Durham, North Carolina, United States Q² Solutions Full time
Job Summary

The Senior Director of Bioanalytical Laboratory Operations is a key leadership position responsible for overseeing the operational management and coordination of resources for the Immunoassay Services Laboratory at Q2 Solutions. This individual will interact with clients, project management, managers, and staff members, providing authoritative guidance on proper procedures and techniques for delivering bioanalytical services.

Key Responsibilities
  • Oversee laboratory operations to ensure compliance with applicable regulations, including 21CFR58 Good Laboratory Practice and ICH E6 Guideline for Good Clinical Practice.
  • Provide oversight and guidance to project management, data management, technical writing, QC, and QA teams to ensure projects are completed on schedule.
  • Monitor project progress and alert management to any delays or issues.
  • Ensure high standards of quality and customer service are maintained, collaborating with Quality Assurance staff to develop and implement effective programs.
  • Establish effective staff selection and training programs to ensure qualified staff are hired and continuously trained.
  • Manage staff in accordance with organization policies and applicable regulations, including planning, assigning, and directing work, appraising performance, and guiding professional development.
  • Participate in budget development and implementation, establishing standards for cost control and waste reduction.
  • Stay up-to-date with new technical developments and implement new capabilities, systems, programs, and procedures as needed.
  • Foster a unified culture and facilitate collaboration, cooperation, sharing of information, and teamwork.
  • Lead continuous improvement initiatives to increase quality of services and operational efficiency.
Requirements
  • PhD with 7 years of regulated immunoassay experience preferred or master's degree with 7-10 years of CRO experience or bachelor's degree in biology/chemistry/biochemistry or related field with 15+ years of experience required or equivalent combination of education, training, and experience in GLP environment.
  • Minimum of 5 years of supervising a team required.
Preferred Qualifications
  • In-depth knowledge of laboratory operations procedures and applicable laboratory testing regulations.
  • Working knowledge of quality assurance and quality control principles and in-depth knowledge of company-specific program requirements.
  • Knowledge of occupational safety and health rules and regulations.
  • Excellent written and oral communication skills.
  • Excellent client management and problem resolution skills.
  • Excellent financial management skills.
  • Effective mentoring and coaching skills.
  • High ethical standards.
  • Strong operational focus.
  • Ability to motivate a team to achieve shared goals within performance standards and budget.
  • Ability to assess and prioritize multiple tasks, projects, and demands.
  • Ability to make effective and persuasive presentations on controversial or complex topics to clients, senior management, and other stakeholders.
  • Ability to establish and maintain effective working relationships with coworkers, managers, and clients.

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