University of Minnesota

About the Job

This position is for a 12-month appointment.

Research Motivation:

Global deaths due to limited access to treatment for end stage kidney disease (ESKD) is estimated to reach 9.1 million by 2030. This burden is overwhelmingly felt by patients in low and middle income countries (LMICs). Less than 10% of those who need treatment in LMICs are able to access it. Our team, which includes partner nephrologists in the U.S. and in Nigeria, have identified peritoneal dialysis (PD) as the path toward increased access. However, limited availability of peritoneal dialysate has limited the impact of past attempts to introduce PD as a treatment modality.

The technology being developed in our lab is a biopharmaceutical device for rapid, on-demand compounding of the necessary dialysate, near the point of care. The system produces water-for- injection, mixes in the necessary solutes, and then performs aseptic bagging of the solution in 2L bags. Each “batch” produces 25 bags.

As part of the development of this technology and ensuring adequate shelf life for the fluid produced, we must evaluate the microbiological performance and the effectiveness of integrated disinfection controls. In this project, you would be assisting with this evaluation, which will drive the development of the device. This work will include comparative microbiological testing at interfaces within the compounding device prototype, assessment of the long-term stability of the fluid, and translating these findings into recommendations for the system design.

Who are we looking for?

The Wright Research Group is seeking a postdoctoral associate with a background in microbiology, biology, molecular biology, biochemistry, cell biology, or equivalent (see qualifications). The project will involve utilizing protocols written by the US Pharmacopeia (USP) to quantify the potential presence of biological contamination in fluid samples produced by a prototype device for compounding peritoneal dialysis fluid. The specific USP protocols of interest are 61, 62 (bioburden testing), 71 (sterility testing), and 85 (bacterial endotoxin testing). The researchers will be asked to optimize lab-specific protocols and run the protocols at a larger scale for prototype testing. The candidate is also expected to perform the biological testing detailed in the aforementioned protocols in the UMN Bio-Nano Lab.

The compounding device being developed is currently going through tech translation towards a start-up company founded by members of the Wright Lab. Interest in entrepreneurship and tech translation is a plus.

About the Job:

In this position you will be expected to optimize processes to minimize contamination of peritoneal dialysis fluid. This role is responsible for creating processes to ensure bioburden reduction and then developing robust assays and quality controls to measure and verify the process met its intent. You are expected to perform high level experimental and theoretical research. Your primary research project will focus on microbiological testing of dialysate solutions, but you will have some latitude to study a variety of scientific topics chosen through mutual agreement and within the constraints of available funding.

Principal Duties and Responsibilities:

• You will be responsible for performance of routine quality control (QC) testing such as bioburden, endotoxin, and microbial ID analysis.
• In this context, you might be expected to generate new research ideas and lead development of new research proposals.
• You will also be expected to design and develop a cleaning-in-place (CIP) system for efficient and reliable equipment cleaning.
• In this position, you will collaborate with a highly interdisciplinary team within the University of Minnesota and partner organizations. Such collaborations may also extend to leading the communication with industrial partners through regular progress reports and supporting technology transfer processes where applicable.
• You will also be expected to participate in preparing, presenting, and discussing data with study investigators.
• You will be expected to author, co-author, and otherwise collaborate on preparing publications for peer review describing research results, assisting with the preparation of progress reports as required by funding agencies, preparation of presentations for conferences, attendance at grant review meetings, and assisting with proposal preparation.
• You will also be expected to participate in preparing, presenting, and discussing data with study investigators.
• As a postdoctoral associate, you will be encouraged to serve as a leader on your research team by mentoring graduate students, undergraduate students, and/or lab technician research team members. This may include advice on technical questions, data analysis, discussions on the development of research plans, preparation of manuscripts and reports, participating in the application / execution of established techniques to other projects, and helping them to develop and pursue their own independent research as a co-author.
• You might be acting lead on research projects and expected to effectively coordinate research activities within the project team, communicate project needs, and provide regular updates on project progress to the lab group and Principal Investigator.
• You will have joint responsibility for the organization and management of laboratories under the faculty mentor's supervision ensuring all lab members follow all safety protocols, properly recording data from experimental and numerical research and promptly backing up all data.
• While in this position you may also have the opportunity to teach courses offered in our department. These duties would be to prepare and deliver lectures, prepare homework assignments, quizzes and exams, hold office hours, assess student work, supervise the teaching assistants and manage the administration of the course.

Work Already Completed Toward This Aim:

• A protocol for USP 61 has been written and validated
• A protocol for USP 85 has been written and validated using a endotoxin kit
• Ultra-Membrane filtration has been selected for optimum removal of endotoxin
• The water system train has been validated and has demonstrated its capability to produce water that meets Water for Injection (WFI) quality standards.
• Initial ideas for a cleaning-in-place (CIP) system have been drafted but not implemented.

Breakdown of Duties/Responsibilities:

• (1)optimizing and implementing research protocols and safety procedures related to any new experimental work, including quality control of reagents, (10%)
• (2) performance of routine QC testing such as bioburden, endotoxin, and microbial ID analysis, (10%)
• (3) collecting and analyzing research data, (35%)
• (4) develop a cleaning-in-place (CIP) system, (10%)
• (5) keeping a detailed record of research work including summarizing research findings for presentations, conference/journal publication, and proposal preparation, (20%)
• (6) assisting with the ordering and procurement of supplies and equipment and with general maintenance of the laboratory, (5%)
• (7) contributing to the training of Wright Lab undergraduate and graduate researchers in the lab, to include attending lab group meetings, providing feedback on experimental design and during presentations and design reviews, among other mentorship interactions, (5%)
• (8) other duties as assigned. (5%)

Qualifications

• Required qualifications include:
• PhD (or equivalent terminal degree) in relevant discipline, in biological sciences, microbiology, chemical engineering, biomedical engineering, or mechanical engineering
• Experience with funded research and grants
• Scientific writing skills demonstrated through peer-reviewed publications
• Experience with aseptic lab technique and working in biosafety cabinets
• Experience with microbial culturing techniques for both BSL1 and BSL2 microorganisms
• Ability to acquire accurate, reportable data
• Strong project and time management skills
• Preferred qualifications include:
• Strong understanding and experience in handling and sterilization of medical devices
• Experience in B&F testing, microbial ID analysis, endotoxin testing, and bioburden testing
• 1+ years of experience with sterile product design and related standards
• Deep understanding in a variety of sterilization techniques
• Strong research, writing, and communication skills
• Experience working in interdisciplinary teams
• Strong interpersonal and mentoring skills
• Experience with bioburden testing via the membrane filtration, OD600, and CFU methods
• Experience with a 96 well UV-vis plate reader
• Familiarity with GLP (Good Laboratory Practices)

About the Department

The Department of Mechanical Engineering has an internationally recognized faculty, and is part of the College of Science and Engineering, the highly interdisciplinary college of engineering, physical sciences, and mathematics.

Pay and Benefits

Pay Range: $61,008 - $65,000; depending on education/qualifications/experience

Please visit the Benefits for Postdoctoral Candidates website for more information regarding benefit eligibility.

• Competitive wages, paid holidays, and generous time off
• Continuous learning opportunities through professional training
• Medical, dental, and pharmacy plans
• Healthcare and dependent care flexible spending accounts
• University HSA contributions
• Disability and life insurance
• Employee wellbeing program
• Financial counseling services
• Employee Assistance Program with eight sessions of counseling at no cost

How To Apply

Applications must be submitted online. To be considered for this position, please click the Apply button and follow the instructions. You will be given the opportunity to complete an online application for the position and attach a cover letter and resume.

Additional documents may be attached after application by accessing your "My Job Applications" page and uploading documents in the "My Cover Letters and Attachments" section.

To request an accommodation during the application process, please e-mail employ@umn.edu or call (612) 624-8647.

Diversity

The University recognizes and values the importance of diversity and inclusion in enriching the employment experience of its employees and in supporting the academic mission. The University is committed to attracting and retaining employees with varying identities and backgrounds.

The University of Minnesota provides equal access to and opportunity in its programs, facilities, and employment without regard to race, color, creed, religion, national origin, gender, age, marital status, disability, public assistance status, veteran status, sexual orientation, gender identity, or gender expression. To learn more about diversity at the U: http://diversity.umn.edu

Employment Requirements

Any offer of employment is contingent upon the successful completion of a background check. Our presumption is that prospective employees are eligible to work here. Criminal convictions do not automatically disqualify finalists from employment.

About the U of M

The University of Minnesota, Twin Cities (UMTC)

The University of Minnesota, Twin Cities (UMTC), is among the largest public research universities in the country, offering undergraduate, graduate, and professional students a multitude of opportunities for study and research. Located at the heart of one of the nation's most vibrant, diverse metropolitan communities, students on the campuses in Minneapolis and St. Paul benefit from extensive partnerships with world-renowned health centers, international corporations, government agencies, and arts, nonprofit, and public service organizations.

At the University of Minnesota, we are proud to be recognized by the Star Tribune as a Top Workplace for 2021, as well as by Forbes as Best Employers for Women and one of America’s Best Employers (2015, 2018, 2019, 2023), Best Employer for Diversity (2019, 2020), Best Employer for New Grads (2018, 2019), and Best Employer by State (2019, 2022).

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