Scientist - Analytical, NIIMBL
Company: University of Delaware
Posted on: January 20, 2023
Pay Grade: 33E
Context of the Job:
Under the limited direction of the Director of Technical
Operations, the Analytical Scientist is responsible for working
with a broad array of analytical instrumentation in support of
diverse projects and samples relevant to the biopharmaceutical
industry at the National Institute for Innovation in Manufacturing
Biopharmaceuticals (NIIMBL). The work will involve 21CFR58
compliant data collection and analysis and work that is
collaborative with cell culture, bioreactor, and downstream
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 analytical support for bioprocess development. Prepare
technical reports and data summaries in a timely manner. Maintain
accurate and well-organized laboratory records.
* Adhere to 21CFR58 GxP guidelines in execution of work.
* Contribute to the development and/or improvement of technical
capabilities within Analytical Development as well as initiatives
to improve group efficiency.
* Evaluate suitability of new methods and qualify methods for
intended uses. Author method development and qualification reports
and SOPs for test methods.
* In collaboration with the Analytical lead, implement new LC/MS
technologies and approaches in support of assessment of critical
quality attributes (CQAs) for biologics and cell and gene therapy
* Assist in assay validation, testing external protocols, writing
SOPs, and generating transfer documents for external groups
* Maintain full documentation of analyses in electronic lab
notebook. Performing tracking and trend analysis of method
* Maintain analytical equipment in a calibrated and operational
* Perform routine existing assays to support upstream/downstream
process characterization and high throughput screening
* Perform basic analytical procedures including sample dilutions,
centrifugation, and optical density analyses.
* Using liquid handlers and other automation equipment to improve
efficiency and throughput
* Develop, qualify, and troubleshoot chromatography (HPLC, UHPLC)
and CE (icIEF and CE-SDS) based methods.
* Develop, qualify, and troubleshoot other analytical assays such
as ELISA, Western, SDS-PAGE, UV-Vis's spectrophotometry,
BCA/Bradford, glycosylation, cell counting metabolite profiling,
blood gas analysis, etc. to facilitate sample characterization.
* Compiling, analyzing, and interpreting data to present in team
meetings while working cross-functionally to develop new experiment
to support project goals
* Draft and revise SOPs.
* Maintain detailed documentation of lab activities and tabulation
* Compile data generated to present at team meetings and present
and discuss this data.
* Participate in training cross functional team members in cell
bank creation and expansion
* Author, review and edit technical reports.
* Stay current with relevant technologies and scientific
* Perform job-related duties as assigned.
* A PhD in analytical chemistry, biochemistry or relevant
discipline is preferred.
* At least 2 years of industrially relevant bioreactor experience
is required with preference for experience in a 21CFR58-compliant
* Hands-on experience with a relevant analytical instrumentation is
* Knowledge of biotech manufacturing process and equipment.
* Experience in developing high throughput analytical assays for
bioprocess projects is highly desired.
* Possess a contribution mindset fueled by an inner drive to take
initiative without being directed.
* 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
* Excellent interpersonal and managing skills with the desire to
work collaboratively and effectively in a team environment.
* Ability to demonstrate effective leadership through
communication, respect, influence, persuasion, and trust.
* Excellent problem solving and critical thinking skills.
* Excellent writing, communication, and presentation skills.
* Strong MS Excel, PowerPoint, Word, and Microsoft Project
* Excellent organization and planning skills.
* Strong attention to detail and ability to adhere to standards
* Ability to function in a rapidly changing environment.
Notice of Non-Discrimination, Equal Opportunity and Affirmative
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
Keywords: University of Delaware, Newark , Scientist - Analytical, NIIMBL, Other , Newark, Delaware
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