The Senior Director of Bioanalytical Laboratory Operations is responsible for operational management and coordination of resources for the Immunoassay Services Laboratory. The Senior Director interacts with clients, the project management organization, Managers, and other staff members and will act as an authoritative resource regarding the proper procedures and techniques required for delivery of bioanalytical services. The Senior Director will have a high level of responsibility for the conduct of projects and play an active role mentoring and guiding junior members of the team. This individual will be the primary point of contact for Q2 Solutions external customers and should provide exceptional customer service while ensuring that all work meets our scientific standards. This individual will continually seek out better ways to plan and execute projects and have a strong leadership presence throughout the organization driving quality science and process improvements and are responsible for the operation, leadership, direction and administration of Bioanalytical Lab Operations in accordance with applicable regulations governing clinical laboratories. Perform work in accordance with 21CFR58 Good Laboratory Practice and ICH E6 Guideline for Good Clinical Practice.
Responsibilities
- Oversee the overall operations of the bioanalytical immunoassay laboratory support organization. Ensure that laboratory operations meet or exceed all applicable regulatory requirements.
- Responsible for overseeing multiple disciplines and/or functional areas.
- Provide oversight and guidance to the Project Management Organization, Data Management, Technical Writing, QC and QA to ensure projects are completed on schedule.
- Monitor the progress of all projects in the group and alert management if work falls behind schedule.
- Ensure that the highest standards of quality and customer service are maintained. Collaborate with Quality Assurance staff on development and implementation of effective programs.
- Establish effective staff selection and training programs to ensure that qualified staff are hired and continuously trained in order to remain current on lab deliverables.
- Manage staff in accordance with organization’s policies and applicable regulations. Responsibilities include planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems. Approve actions on human resources matters.
- Participate in the development and implementation of the department's operating budget. Establish standards for cost control and waste reduction. Monitor utilization patterns of services and advise on developing trends in bioanalytical service needs.
- Keep abreast of new technical developments, implement new capabilities, systems, programs and/or procedures in the department as needed. Lead continuous improvement initiatives to increase quality of services and operational efficiency.
- Foster a unified culture and facilitate collaboration, cooperation, sharing of information and teamwork.
- Maintain a strong leadership presence throughout the organization by driving scientific quality and process improvement initiatives, in collaboration with management, lead the development of strategies and priorities in the Immunoassay group.
- Evaluate performance of assigned staff and provide feedback on areas of potential improvement in quality and efficiency.
- Ensure projects are archived in accordance with appropriate study direction and SOPs.
- Participate in weekly scheduling, project updates and revenue meetings and inform on project progress.
- Lead customer visits.
- Work with business development and scientific staff to prepare quotes for assigned customers.
- Responsible for upholding all safety standards, discipline guidelines and regulatory compliance requirements with all assigned staff.
Minimum Required Education and Experience
- 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.
Required Knowledge Skills and Abilities
- In depth knowledge of Lab 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.
