at University of Delaware in Newark, Delaware, United States
Technical Operations Director, NIIMBLApply now (https://secure.dc4.pageuppeople.com/apply/858/gateway/default.aspx?c=apply&lJobID=497285&lJobSourceTypeID=796&sLanguage=en-us) Job no: 497285
College / VP Area:Research Office
Work type: Staff
Categories: Research & Laboratory, Full Time, Program/Project Management
Context of the Job:
Under the limited direction of the Institute Director, the Director of Technical Operations is accountable for all technical operations including laboratory infrastructure, safety, and oversight of a large team of individuals who may be working in up to three shifts with 365 day per year operations at the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL). The work involves a combination of strategic decision-making with stakeholders from NIIMBL leadership, as well as 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, antibody-drug conjugates, bispecific antibodies, gene therapy vectors, and cell therapies, among others.
+ Provide strategic leadership for the entire portfolio of NIIMBL’s technical operations, including overall accountability for all activity.
+ Provide overall accountability for laboratory safety including compliance and training of all relevant individuals.
+ Develop a quality management system and ensure technical operations are aligned with the quality management system.
+ Work with senior NIIMBL individuals to prioritize and effectively execute a diverse array of high profile, high impact projects.
+ Lead, manage and collaborate with a broad-based team of technical scientists and staff with a range of skills and experiences, and including PhD-level specialists, senior investigators and laboratory leads, as well as contracted staff.
+ Serve as high-level resource for NIIMBL leadership and for NIIMBL Committees in the execution of NIIMBL’s technical operations, ensuring they meet the needs of the biopharmaceutical manufacturing ecosystem.
+ Partner with diverse global companies to meet the needs of NIIMBL project teams.
+ Work with Office of General Counsel on matters related to NIIMBL technical operations.
+ Oversee management of NIIMBL laboratories including planning, design, renovation of existing space and of possible future space as well as provide space planning.
+ 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.
+ Coordinate tours and visits from the public to ensure safe activities and preservation of confidential information.
+ Oversee and manage data systems for safety including EHS BioRaft.
+ Oversee and manage lab hazard signage.
+ Develop and execute a lab exit plan and lab cleanout plan.
+ Coordinate and lead all teaching lab activities.
+ Serve as lead contact for laboratory tours.
+ Other duties as assigned.
+ Advanced degree in job-related field preferred and a minimum of 20 years of relevant experience required including in 21CFR58 GxP operations.
+ Experience in leading and managing a team of diverse individuals in a laboratory setting.
+ Significant project management training and experience.
+ 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 think strategically and to recognize new opportunities.
+ Ability to establish and maintain positive working relationships with others, both internally and externally, to achieve the goals of the organization.
+ Demonstrates an understanding and consideration of the differing needs and concerns of individuals with varying identities, cultures, and backgrounds.
+ Committed to fostering a workplace culture of belonging, where diversity is celebrated, and equity is a core value
Notice of Non-Discrimination, Equal Opportunity and Affirmative Action
The University of Delaware does not discriminate against any person on the basis of race, color, national origin, sex, gender identity or expression, sexual orientation, genetic information, marital status, disability, religion, age, veteran status or any other characteristic protected by applicable law in its employment, educational programs and activities, admissions policies, and scholarship and loan programs as required by Title IX of the Educational Amendments of 1972, the Americans with Disabilities Act of 1990, Section 504 of the Rehabilitation Act of 1973, Title VII of the Civil Rights Act of 1964, and other applicable statutes and University policies. The University of Delaware also prohibits unlawful harassment including sexual harassment and sexual violence.
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