Downstream Operations Scientist

The Chronicle Of Higher Education, Inc.; Newark (DE); On-site; USD 75,000 - 110,000; Full time

Job summary

The University of Delaware is seeking a Downstream Operations Scientist to lead downstream purification unit operations for materials from bioreactors and shake flasks within NIIMBL. This role supports NBC biopharmaceutical workflow at Newark, DE, and involves 21 CFR 58 compliant processes and data analysis in a modern laboratory.

Responsibilities include developing purification and formulation steps, DoE studies, process parameter optimization, and collaboration with bioreactor and analytics

Qualifications

• Masters in chemical engineering with 5 years of industrially relevant downstream purification experience; PhD with 2 years acceptable.
• Experience in a 21CFR58-compliant GxP environment preferred.
• Hands-on experience with chromatography skids and bioprocess equipment.
• Knowledge of biotech manufacturing processes and equipment.
• Strong writing, communication and collaboration skills.

Responsibilities

• Lead downstream purification unit operations for biopharmaceuticals.
• Adhere to 21 CFR 58 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 chromatography, filtration, TFF and bulk filling.
• Develop new primary recovery and chromatography unit operations for scale-up.
• Collaborate with analytical team to adapt methods such as HPLC, SDS-PAGE, enzyme activity and endotoxin assays.
• Document all work in electronic lab notebook and perform tracking and trend analysis.
• Draft and revise SOPs and batch records.

Skills

Downstream purification

Chromatography

Process development

DoE studies

Data analysis

GxP compliance

DeltaV control system

Education

Master of Science in Chemical Engineering

PhD in Chemical Engineering

Tools

DeltaV control system

Job description

University of Delaware

Equal Employment Opportunity Statement

The University of Delaware is an Equal Opportunity Employer whichencourages applications from Minority Group Members, Women,Individuals with Disabilities and Veterans. The University's Noticeof Non-Discrimination can be found at http://www.udel.edu/aboutus/legalnotices.html

Job No: 502528

Work Type: Staff

Location: Newark, DE

Categories: Research & Laboratory, Full Time

Pay Grade: 33E

Context of the Job:

The Downstream Operations Scientist is responsible for leadingdownstream purification unit operations for materials frombioreactors and shake flasks with culture volumes ranging from250mL to 50L in scale at the National Institute for Innovation inManufacturing Biopharmaceuticals (NIIMBL). The work will involve21CFR58 compliant downstream operations and data analysis,including utilizing automation systems. The scientist will alsocollaborate with bioreactor specialists and an analytical team.

Among other activities, NIIMBL executes technical projects thatadvance the readiness levels of relevant technologies, assays, andmethods. The scopes of scientific projects generally include manyorganizations as partners and collaborators such as scientists fromseveral large and small companies, a scientist from a Federalagency, and a scientist from a University. Many of these projectswill be hosted at the University of Delaware in a state-of-the-artlaboratory facility purpose-built for such studies. These projectswill involve a diverse set of technologies and approaches andaddress drug substance, drug product, and analytical needs by theindustry appropriate to several types of biopharmaceuticals:vaccines, therapeutic proteins and antibodies, antibody-drugconjugates, bispecific antibodies, gene therapy vectors, and celltherapies, among others.

Major Responsibilities

• Serve as a lead technical scientist on multiple projectsinvolving downstream purification unit operations for themanufacture of industrially relevant products and relatedactivities.
• Adhere to 21CFR58 GxP guidelines in execution of work.
• Set-up, operate, troubleshoot, maintain, and clean downstreambioprocessing equipment.
• Use manufacturing experience to identify process parameters anddefine their setpoints.
• Perform DoE studies to confirm the impact of process parameterson impurity levels, product recovery, and potency.
• Characterize performance of existing purification andformulation unit operations, including column chromatography (e.g.,ProA, SEC, CEX, AEX), filtration, TFF, and bulk filling.
• Develop new primary recovery unit operations such ascentrifugation, homogenization, flocculation, tangential-flowfiltration (TFF), and depth filtration.
• Develop new chromatography unit operations, from screening andcharacterization to optimization and initial scale-up.
• Optimize buffer compositions to improve the stability andsolubility of target molecules.
• Collaborate with an analytical team to adapt and troubleshootresearch analytical methods such as HPLC, SDS-PAGE, enzyme activityand endotoxin assays to quantify yield, activity, and purity atvarious 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 dataanalysis, and present data to teams.
• Partner with Informatics Infrastructure team on deployingstructured data capture systems.
• Draft and revise SOPs and batch records.
• Maintain detailed documentation of lab activities andtabulation of data.
• Compile data generated to present and discuss at teammeetings.
• Author, review and edit technical reports and manuscriptsintended for publication.
• Stay current with relevant technologies and scientificliterature.
• Perform other job-related duties as assigned.

Qualifications:

• A Masters in chemical engineering or relevant life sciencediscipline and 5 years of industrially relevant downstreampurification experience is required with preference for experiencein a 21CFR58-compliant GxP environment, or a PhD in chemicalengineering or relevant life science discipline and 2 years ofindustrially relevant downstream purification experience isrequired with preference for experience in a 21CFR58-compliant GxPenvironment.
• Hands-on experience with a range of downstream unit operationsand control systems, experience with DeltaV preferred.
• Operates chromatography skids and other bioprocess equipmentfor purification of industrially relevant materials.
• Knowledge of biotech manufacturing process and equipmentincluding cell culture, depth and tangential flow filtration,column chromatography, protein purification and formulation and/orbuffer and media operations.
• Possess a contribution mindset fueled by an inner drive to takeinitiative without being directed.
• Excellent interpersonal and managing skills with the desire towork collaboratively and effectively in a team environment.
• Ability to demonstrate effective leadership throughcommunication, 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 Projectskills.
• Excellent organization and planning skills.
• Strong attention to detail and ability to adhere to standardsprocedures.
• Ability to function in a rapidly changing environment.

Notice of Non-Discrimination and Equal Opportunity

The University of Delaware does not discriminate against any personon the basis of race, color, national origin, sex, gender identityor expression, sexual orientation, genetic information, maritalstatus, disability, religion, age, veteran status or any othercharacteristic protected by applicable law in its employment,educational programs and activities, admissions policies, andscholarship and loan programs as required by Title IX of theEducational Amendments of 1972, the Americans with Disabilities Actof 1990, Section 504 of the Rehabilitation Act of 1973, Title VIIof the Civil Rights Act of 1964, and other applicable statutes andUniversity policies. The University of Delaware also prohibitsunlawful harassment including sexualharassment and sexualviolence.

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