PAY GRADE:  31E

CONTEXT OF THE JOB:

The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) is a large-scale public-private effort dedicated to supporting the manufacturing of biopharmaceuticals. 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. NIIMBL 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. Institutionally at the University of Delaware, NIIMBL reports to the Vice President for Research, Scholarship & Innovation.

In collaboration with our partners, NIIMBL facilitates the development and commercialization of rapid, flexible, and cost-efficient biopharmaceutical manufacturing technologies.  This includes improved processes for the further industrialization of existing products, such as vaccines, monoclonal antibodies, antibody drug conjugates, bispecifics, and other therapeutic proteins; emerging products such as cell and gene therapies; and the development of reference standards and measurement technologies to improve manufacturing efficiencies and ensure proper characterization of materials.  NIIMBL engages in advancing technologies related to drug substance, drug product, and process control and analytics through novel approaches and advancements such as integrated continuous processing, advanced process control and monitoring, process integration and intensification, novel and real-time analytical technologies, and automation, among other areas.

MAJOR RESPONSIBILITIES:

• Coordinates operational activities across the NIIMBL facilities at UD, which host a diversity of equipment and research projects related to drug substance, drug product, and process control and analytics.  Provides support services to University and visiting researchers and faculty. 
• Develops and implements policies, procedures, and standards for lab operations to ensure the efficiency, effectiveness, and quality control of the laboratory and compliance with federal, state, and university regulations and standards.
• Supervises NIIMBL laboratory staff
• Review and approve research reports written by laboratory staff
• Trains and develops laboratory staff in knowledge and behaviors
• Ensures all users of NIIMBL laboratories including visiting researchers are properly trained for the work they do, including safety training
• Accountable for safe operation of all NIIMBL laboratory facilities and ensures that all users of NIIMBL laboratories follow safety and other procedures.
• Provides support and assistance related to facilities and equipment training, issues and repairs.
• Develops instructional material and laboratory manuals for demonstration and/or dissemination for laboratory operation, equipment and facilities.
• Responsible for safety training and compliance and develops and/or conducts safety training workshops.
• Supervises the ordering, inventory, storage, and maintenance of supplies, lab ware, and instruments essential to the operation of the lab.
• Ensures that the instruments in the laboratory remain operational, appropriately calibrated and adjusted for peak performance.
• Oversees the implementation, operation, and continued upgrading of software systems for instrument use.  Implement software systems for data acquisition, analysis, and sharing.
• Performs miscellaneous job-related duties as assigned.

QUALIFICATIONS:

• Bachelor’s degree in chemical engineering, chemistry, biochemistry, or biology and at least five years of directly related experience or equivalent combination of education and experience.
• Must have a thorough knowledge of and experience managing people in a biopharmacetical development or QC laboratory, pilot plant or commercial manufacturing operations environment.
• Experience with process control and data systems.
• Ability to develop and deliver presentations and internal training materials.
• Ability to gather and analyze statistical data and generate lab operation reports.
• Effective interpersonal and communication skills and the ability to work effectively with a wide range of constituencies in a diverse community. 
• Comprehensive knowledge of biopharmaceutical concepts, scientific approach and methodologies.
• Skill in organizing resources and establishing priorities.
• Strategic planning skills and experience.
• Excellent leadership and interpersonal skills