Bioanalytical Scientist @ ProKidney

Join us in developing pioneering therapies that aim to transform the treatment of CKD and change patients’ lives. Our technology is designed to treat diseased kidneys using a patient’s own cells and may prevent or delay dialysis or transplant.

The Bioanalytical Development team develops and implements innovative flow cytometry-based immunophenotyping assays for comprehensive product characterization. As an Applied Scientist, you will play a key role in supporting ProKidney’s development of the Phase 3 clinical trial candidate rilparencel renal cell therapy product. ProKidney is an equal opportunity employer.

Key Responsibilities:

Employ multiparametric flow cytometry to support daily and long-term operations related to product characterization and/or product release initiatives.
Participate in programs to qualify and validate flow assays, as well as implement automation of workflows.
Evaluate reference standards, assay controls, and critical materials and reagents, and ensure data integrity and good documentation.
Perform all aspects of flow cytometry testing and analysis, including instrument calibration and set-up, as well as preparing and maintaining good quality reagents.
Support the development of SOPs, test procedures, assay qualification and validation protocols.
Contribute to technology transfers (internal and external).
Collaborate with cross-functional teams to facilitate clinical Phase 3 activities as well as BLA-enabling workstreams.

Summarize data for presentations and reports with accountability for accuracy to ensure quality and integrity, and communicate results internally at group meetings and with colleagues at other sites.

Requirements	Description
Education/Training	Bachelor’s or Master’s degree in a biological science discipline required (e.g., developmental biology, cell biology, immunology, or related pharmaceutical science).
Experience	5+ years of relevant experience with multiparametric flow cytometry applications in a CMC analytical development or quality control environment following Bachelor’s degree or relevant industry experience required.
Skills/Abilities	• Strong background and experience in multiparametric flow cytometry assays including immunophenotyping as well as immune based functional assays is required. • Hands-on experience with a variety of high-content and/or spectral flow cytometry data analysis and bioinformatic tools (e.g., BD FACSuite and FlowJo), supporting multi-color flow cytometry instruments (e.g., BD FACSLyric and Cytek Aurora) is highly desirable. • Experience with establishing automated lab processes and analyzing large numbers of data files is recommended. • Broad knowledge in a variety of analytical methods for the characterization and release of cell-based therapies is a plus. • Relevant experience in analytical development in a CMC setting, including assay qualification, validation and tech transfer for biologics or cell therapy is a plus. • Detail-oriented strong organizational, time management, and multi-tasking skills with demonstrated accountability. • Ability to work within a team-oriented fast-paced collaborative environment. • Proficiency in data analysis, and ability to effectively use information technology (i.e., MS Outlook, Word, Excel, PowerPoint; GraphPad Prism, SAS JMP; Tableau, Spotfire). • Familiarity with laboratory information systems used for reporting results and retrieving information. • Must be legally authorized to work in the US.

ProKidney is an Equal Opportunity Employer. All applicants are considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. We are committed to the principles of equal employment opportunity for all employees with a work environment free of discrimination and harassment.

Join us in developing pioneering therapies that aim to transform the treatment of CKD and change patients’ lives. Our technology is designed to treat diseased kidneys using a patient’s own cells and may prevent or delay dialysis or transplant.

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