University of Delaware
Equal Employment Opportunity Statement
The University of Delaware is an Equal Opportunity Employer which
encourages applications from Minority Group Members, Women,
Individuals with Disabilities and Veterans. The University's Notice
of Non-Discrimination can be found at
http://www.udel.edu/aboutus/legalnotices.html
Job No: 503941
Work Type: Staff
Location: Newark, DE
Categories: Research & Laboratory, Full Time,
Program/Project Management
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.
Notice of Non-Discrimination and Equal Opportunity
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 VI
and 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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