Technical Operations Director, NIIMBL

Pay Grade: 90E

Context of Job:

Under the limited direction of the Institute Director, the Director, Technical Operations is accountable for all technical operations including laboratory infrastructure, safety, and oversight of a team of individuals. In the future, this team may be working three shifts with 365 day per year operations at the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL). The work involves tactical decision-making to support safe and effective laboratory operations.

NIIMBL is a large-scale effort dedicated to supporting the manufacturing of biopharmaceuticals, and it is established by a cooperative agreement with the National Institute of Standards and Technology (NIST) as a public/private consortium of a diverse set of member organizations, including industry, academia, non-profit organizations, state governments, and federal agencies. NIIMBL is a member of the Manufacturing USA network of institutes funded by the federal government to advance United States competitiveness in advanced manufacturing innovation. Institutionally at the University of Delaware, NIIMBL reports to the Vice President for Research, Scholarship & Innovation.

The most high-profile activities that NIIMBL does are the execution of technical projects to advance the readiness levels of relevant technologies, assays, and methods. These projects include scopes of scientific work that generally include many organizations as partners and collaborators. For example, a project may involve experimental studies, at a level consistent with best practices found in the biopharmaceutical industry, and include scientists from several large and small companies, a scientist from a Federal agency, and a scientist from a University. Many of these projects will be hosted at the University of Delaware in a state-of-the-art laboratory facility purpose-built for such studies. These projects will involve a diverse set of technologies and approaches and address drug substance, drug product, and analytical needs by the industry appropriate to several types of biopharmaceuticals: vaccines, therapeutic proteins and antibodies, bispecific antibodies, and gene therapy vectors, among others. To accelerate innovation and support standards development, the Tech Ops team hosts and performs NIIMBL technical work that is best done at HQ because the work requires a collaborative environment and is work most effectively performed at a neutral site; this is a full-time, in person, position.

Major Responsibilities:

• Demonstrates NIIMBL’s Core Values in daily conduct and ensures all decisions, actions, and teamwork practices align with the organization’s Business Principles.
• Overall accountability for the entire portfolio of NIIMBL’s technical operations, including prioritization of activities through dialogue with NIIMBL Leadership and NIIMBL Program Leaders from industry.
• Overall accountability for laboratory safety including compliance and training of all relevant individuals.
• Accountability to manage Technical Operations Resources and Assets including:
  • Staff: professional development and assignment to projects
  • Equipment: commissioning and maintenance of highly valuable and specialized equipment infrastructure
  • Finances: tracking and alignment with available budget
  • Space: effective and efficient use of available space
  • Materials, data, and intellectual property: maintaining access control over valuable assets
• Accountability to manage Technical Operations Activities including:
  • Electronic laboratory notebook system infrastructure
  • Laboratory information management system infrastructure
  • Relevant policies and procedures
  • Visitors to the laboratory including tours and hosted scientists
  • Continuous improvement to increase efficiencies and productivity
• Serve as high-level resource for NIIMBL leadership in the execution of NIIMBL’s technical operations, ensuring they meet the needs of the biopharmaceutical manufacturing ecosystem.
• Ensure compliance with federal rules and regulations in the conduct of sponsored research including conflict of interest policies, research involving human subjects, export control laws, etc.
• Reinforce and advocate for NIIMBL’s Core Values and Business Principles
• Perform other job-related duties as assigned.

Qualifications:

• Advanced degree in job-related field preferred and a minimum of 20 years of relevant experience required including in 21CFR58 GxP operations, or equivalent combination of education and experience.
• Experience in leading and managing a team of diverse individuals in a laboratory setting.
• Significant project management training and experience.
• Significant experience establishing and growing a laboratory-based team in an industry or government environment.
• Effective interpersonal, oral and written communication skills.
• Ability to communicate effectively with diverse individuals and groups (e.g., federal and state agencies, academic, and industrial communities) both within and outside of NIIMBL.
• Ability to establish and maintain positive working relationships with others, both internally and externally, to achieve the goals of the organization.