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University of Delaware · 1 day ago

Downstream Operations Scientist

Newark, DE

Full-time

Onsite

Mid, Senior Level

2+ years exp

The University of Delaware is seeking a Downstream Operations Scientist to lead downstream purification unit operations at the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL). The role involves executing 21CFR58 compliant operations, collaborating with various teams, and optimizing bioprocessing techniques for biopharmaceutical production.

Higher Education

H1B Sponsor Likely

Responsibilities

Serve as a lead technical scientist on multiple projects involving downstream purification unit operations for the manufacture of industrially relevant products and related activities

Adhere to 21CFR58 GxP guidelines in execution of work

Set-up, operate, troubleshoot, maintain, and clean downstream bioprocessing equipment

Use manufacturing experience to identify process parameters and define their setpoints

Perform DoE studies to confirm the impact of process parameters on impurity levels, product recovery, and potency

Characterize performance of existing purification and formulation unit operations, including column chromatography (e.g., ProA, SEC, CEX, AEX), filtration, TFF, and bulk filling

Develop new primary recovery unit operations such as centrifugation, homogenization, flocculation, tangential-flow filtration (TFF), and depth filtration

Develop new chromatography unit operations, from screening and characterization to optimization and initial scale-up

Optimize buffer compositions to improve the stability and solubility of target molecules

Collaborate with an analytical team to adapt and troubleshoot research analytical methods such as HPLC, SDS-PAGE, enzyme activity and endotoxin assays to quantify yield, activity, and purity at various stages of the manufacturing process

Document all work and analyses in an electronic lab notebook. Perform tracking and trend analysis of method performance

Analyze process performance trends, perform statistical data analysis, and present data to teams

Partner with Informatics Infrastructure team on deploying structured data capture systems

Draft and revise SOPs and batch records

Maintain detailed documentation of lab activities and tabulation of data

Compile data generated to present and discuss at team meetings

Author, review and edit technical reports and manuscripts intended for publication

Stay current with relevant technologies and scientific literature

Perform other job-related duties as assigned

Qualification

Downstream purification experienceChromatography operationsBioprocess equipment operationStatistical data analysis21CFR58 complianceHPLC experienceDeltaV control systemsInterpersonal skillsLeadership skillsProblem solving skillsCommunication skillsOrganizational skillsAttention to detail

Required

At least 2 years of industrially relevant downstream purification experience with preference for experience in a 21CFR58-compliant GxP environment

Hands-on experience with a range of downstream unit operations and control systems

Operates chromatography skids and other bioprocess equipment for purification of industrially relevant materials

Knowledge of biotech manufacturing process and equipment including cell culture, depth and tangential flow filtration, column chromatography, protein purification and formulation and/or buffer and media operations

Possess a contribution mindset fueled by an inner drive to take initiative without being directed

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, and Word skills

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

Preferred

A PhD in chemical engineering or relevant life science discipline

Experience with DeltaV

Company

University of Delaware

Glassdoor4.3

The University of Delaware - a state assisted, privately chartered institution - is a Land Grant, Sea Grant, Space Grant and Carnegie Research University (very high research activity).

Founded in 1743

Newark, DE, US

1001-5000 employees

http://www.udel.edu

H1B Sponsorship

University of Delaware has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

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2025 (77)

2024 (64)

2023 (57)

2022 (32)

2021 (32)

2020 (37)