Scientist - Analytical, NIIMBL
Job no: 497316
College / VP Area: Research Office
Work type: Staff
Categories: Research & Laboratory, Full Time
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 operations experts.
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 projects.
- 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 performance.
- Maintain analytical equipment in a calibrated and operational state
- 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 of data.
- 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 literature.
- 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 GxP environment.
- Hands-on experience with a relevant analytical instrumentation is required.
- 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 skills.
- Excellent organization and planning skills.
- Strong attention to detail and ability to adhere to standards procedures.
- Ability to function in a rapidly changing environment.
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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