Lab Manager, NIIMBL, Research Office
Job no: 494826
Work type: Staff
Categories: Research & Laboratory, Full Time
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.
NIIMBL’s most substantial and high-profile activities include the execution of technical projects to advance the readiness levels of relevant technologies, assays, and methods related to biopharmaceutical manufacturing. These projects include scopes of scientific work that are multi-organizational and involve experimental studies at a level consistent with best practices found in the biopharmaceutical industry. Many of these projects will be hosted at the University of Delaware in the Ammon-Pinizzotto Biopharmaceutical Innovation Center, which serves as NIIMBL’s headquarters, and houses state-of-the-art laboratory facilities 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, antibody-drug conjugates, bispecific antibodies, gene therapy vectors, and cell therapies, among others. The Lab Manager will provide leadership and oversight of research activities occurring within the NIIMBL labs.
- 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 analysis. Interact and coordinate with teams of NIIMBL and UD scientists to ensure effective management and operation of NIIMBL's laboratory infrastructure at UD.
- Develops and implements policies, procedures, and standards for lab operations to ensure NIIMBL laboratory-related activities at the University of Delaware are aligned with Good Manufacturing Practices (21CFR58).
- Oversees the development and implementation of laboratory training, safety, and standard operating procedures across at least two dozen independent projects and laboratories including UD and non-UD scientists, including conducting safety training and developing instructional material and laboratory manuals.
- Oversees the implementation, operation, and continued upgrading of software systems for instrument use to ensure compliance with the NIST Cybersecurity Framework, FedRAMP compliance, and UD IT security policies and related best practices, in coordination with the NIIMBL IT Director and Database Administrator.
- Oversees evaluation, ordering and installation of equipment across the diverse portfolio of NIIMBL technology and workforce projects including both procurement activities as well as interactions with NIIMBL suppliers to provide materials in a form compliant with NIIMBL Bylaws, University policies, and relevant Federal regulations.
- Maintains specialized equipment across the diverse portfolio of NIIMBL technology and workforce projects.
- Be accountable for, and coordinates NIIMBL laboratory-related support activities including interfacing with UD Facilities Planning and Project Delivery; coordinating autoclaves, laboratory coat wash service, and glasswash; regulates waste disposal; and coordinates other permits and registrations as appropriate to different activities.
- Coordinates the ordering of reagents, chemicals, supplies, and other materials across the diverse portfolio of NIIMBL technology and workforce projects including both procurement activities as well as interactions with NIIMBL suppliers to provide materials in a form compliant with NIIMBL Bylaws, University policies, and relevant Federal regulations).
- Performs miscellaneous job-related duties as assigned.
- Bachelor’s degree in chemical engineering, chemistry, biochemistry, biology, or similar field, and at least five years of relevant and related experience, or equivalent combination of education and experience.
- Thorough knowledge of and experience managing complex laboratory operations.
- Significant experience and understanding of Good Laboratory Practices (21CFR58) and a familiarity with current Good Manufacturing Practices (21CFR11, 21CFR210, 21CFR211, and 21CFR600).
- Comprehensive knowledge of research concepts, scientific approach and methodologies; extensive experience in research and leadership.
- Success in working in, and nurturing, an inclusive workplace environment.
- Effective verbal and written communication and interpersonal skills.
- Ability to develop and deliver presentations and internal training materials.
- Ability to work effectively with a wide range of constituencies.
- Strategic planning skills and experience preferred.
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