The Team Lead, Cell Processing at ProKidney plays a critical role in leading advanced manufacturing operations, focusing on cell processing, aseptic processing, and ensuring compliance with cGMP ...
The Team Lead, Cell Processing at ProKidney plays a critical role in leading advanced manufacturing operations, focusing on cell processing, aseptic processing, and ensuring compliance with cGMP ...
The Manufacturing Specialist, Cell Processing at ProKidney is responsible for supporting cell processing operations, ensuring compliance with cGMP guidelines in the development and production of ...
The Manufacturing Specialist, Cell Processing at ProKidney is responsible for supporting cell processing operations, ensuring compliance with cGMP guidelines in the development and production of ...
The Team Lead, Cell Processing at ProKidney plays a critical role in leading advanced manufacturing operations, focusing on cell processing, aseptic processing, and ensuring compliance with cGMP ...
The Team Lead, Cell Processing at ProKidney plays a critical role in leading advanced manufacturing operations, focusing on cell processing, aseptic processing, and ensuring compliance with cGMP ...
The Team Lead, Cell Processing at ProKidney plays a critical role in leading advanced manufacturing operations, focusing on cell processing, aseptic processing, and ensuring compliance with cGMP ...
The Team Lead, Cell Processing at ProKidney plays a critical role in leading advanced manufacturing operations, focusing on cell processing, aseptic processing, and ensuring compliance with cGMP ...
... ProKidney's cGMP site. Reporting to the VP of Quality, this role managers daily floor support operations, ensures compliance with GMP and regulatory requirements, and partners closely with ...
... ProKidney's cGMP site. Reporting to the VP of Quality, this role managers daily floor support operations, ensures compliance with GMP and regulatory requirements, and partners closely with ...
... ProKidney's cGMP site. Reporting to the VP of Quality, this role managers daily floor support operations, ensures compliance with GMP and regulatory requirements, and partners closely with ...
... ProKidney's cGMP site. Reporting to the VP of Quality, this role managers daily floor support operations, ensures compliance with GMP and regulatory requirements, and partners closely with ...
The Team Lead, Cell Processing at ProKidney plays a critical role in leading advanced manufacturing operations, focusing on cell processing, aseptic processing, and ensuring compliance with cGMP ...
The Team Lead, Cell Processing at ProKidney plays a critical role in leading advanced manufacturing operations, focusing on cell processing, aseptic processing, and ensuring compliance with cGMP ...
Sr. TA Coordinator Contractor
Winston Salem, NC · On-site
$19 - $25.25/hr
ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual ...
Sr. TA Coordinator Contractor
Winston Salem, NC · On-site
$19 - $25.25/hr
ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual ...
ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual ...
ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual ...
ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual ...
ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual ...
Associate 2, MS&T
Winston Salem, NC · On-site
Certifications/Licenses: n/a ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry ...
Associate 2, MS&T
Winston Salem, NC · On-site
Certifications/Licenses: n/a ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry ...
QC Microbiology Analyst 3
Winston Salem, NC · On-site
$22.25 - $29.75/hr
Quality Control (QC) Microbiology Analyst III provides support and execution on ProKidney's Environmental Monitoring and Microbiological testing, maintaining GMP compliance, and mentoring junior ...
QC Microbiology Analyst 3
Winston Salem, NC · On-site
$22.25 - $29.75/hr
Quality Control (QC) Microbiology Analyst III provides support and execution on ProKidney's Environmental Monitoring and Microbiological testing, maintaining GMP compliance, and mentoring junior ...
QC Analyst 3
Winston Salem, NC · On-site
$22.25 - $29.75/hr
The QC Analyst will support ProKidney's pipeline, from Phase III clinical development through commercial operations. Responsibilities Writes and executes procedures for analytical method protocols ...
QC Analyst 3
Winston Salem, NC · On-site
$22.25 - $29.75/hr
The QC Analyst will support ProKidney's pipeline, from Phase III clinical development through commercial operations. Responsibilities Writes and executes procedures for analytical method protocols ...
Sr. TA Coordinator Contractor
Winston Salem, NC · Hybrid
$19 - $25.25/hr
ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual ...
Sr. TA Coordinator Contractor
Winston Salem, NC · Hybrid
$19 - $25.25/hr
ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual ...
... ProKidney's cGMP site. Reporting to the VP of Quality, this role managers daily floor support operations, ensures compliance with GMP and regulatory requirements, and partners closely with ...
... ProKidney's cGMP site. Reporting to the VP of Quality, this role managers daily floor support operations, ensures compliance with GMP and regulatory requirements, and partners closely with ...
N/A ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual ...
N/A ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual ...
Experience in writing computer system test scripts, validation protocols and summary reports ProKidney is an equal employment opportunity employer and does not discriminate against any applicant ...
Experience in writing computer system test scripts, validation protocols and summary reports ProKidney is an equal employment opportunity employer and does not discriminate against any applicant ...
Site Office Administrator
Winston Salem, NC · On-site
$16.50 - $22.75/hr
Certifications/Licenses: * n/a ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry ...
Site Office Administrator
Winston Salem, NC · On-site
$16.50 - $22.75/hr
Certifications/Licenses: * n/a ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry ...
Position Summary: The MSAT Research Associate II performs standard laboratory and manufacturing-support activities with increasing independence. The role supports routine process monitoring ...
Position Summary: The MSAT Research Associate II performs standard laboratory and manufacturing-support activities with increasing independence. The role supports routine process monitoring ...
The Sr Director of Quality Control will be responsible for leadership of the various functional responsibilities of the Quality Control department, including QC - Operations, QC - Incoming Raw ...
The Sr Director of Quality Control will be responsible for leadership of the various functional responsibilities of the Quality Control department, including QC - Operations, QC - Incoming Raw ...
Prokidney information
What are the key skills and qualifications needed to thrive as a Clinical Research Associate at Prokidney, and why are they important?
To thrive as a Clinical Research Associate at Prokidney, you need a solid background in life sciences, clinical trial regulations, and a relevant degree such as in biology, nursing, or pharmacy. Familiarity with electronic data capture (EDC) systems, Good Clinical Practice (GCP) certification, and clinical trial management software is typically required. Excellent organizational skills, attention to detail, and strong communication abilities help manage study protocols and collaborate with research teams. These skills ensure the integrity of clinical trials, regulatory compliance, and successful data collection essential for advancing Prokidney's medical innovations.
What does prokidney do?
Prokidney is a healthcare organization focused on kidney health, providing services such as patient education, treatment planning, and support for kidney disease management. Employees in related roles may assist with patient care, medical documentation, and coordination with medical professionals, often requiring knowledge of nephrology and healthcare protocols.
What are ProKidney jobs?
ProKidney jobs refer to positions at ProKidney, a biotechnology company specializing in the development of cell-based therapies for chronic kidney disease. Employees may work in various roles such as research and development, clinical operations, regulatory affairs, manufacturing, and corporate support. Working at ProKidney typically involves contributing to cutting-edge medical innovations aimed at improving kidney health. The company values scientific excellence, teamwork, and a commitment to advancing patient care. Joining ProKidney offers opportunities to be part of a mission-driven organization in the biotech industry.
What is the difference between Prokidney vs Dialysis Technician?
| Aspect | Prokidney | Dialysis Technician |
|---|---|---|
| Certifications | Nephrology-related certifications, patient care training | Certified Hemodialysis Technician (CHT), CPR |
| Work Environment | Nephrology clinics, hospitals, outpatient centers | Dialysis centers, hospitals |
| Industry Usage | Nephrology and kidney care | Renal dialysis services |
| Job Focus | Patient education, kidney disease management | Performing dialysis procedures, equipment setup |
Prokidney professionals focus on managing kidney disease and patient education within nephrology settings, while Dialysis Technicians primarily operate dialysis machines and perform treatments. Both roles require certifications related to dialysis and patient care, but Prokidney roles often involve broader nephrology responsibilities.
What opportunities for professional development and advancement are available for employees at ProKidney?
At ProKidney, employees are encouraged to pursue continuous professional development through in-house training programs, workshops, and cross-functional project involvement. The company fosters a collaborative environment where team members frequently interact with experts in regenerative medicine, clinical operations, and regulatory affairs, enabling them to broaden their skill sets. Career advancement is supported by regular performance reviews and opportunities to take on increased responsibilities or leadership roles as the organization grows. Employees are also encouraged to participate in industry conferences and further education related to biotechnology and healthcare innovation.
What is a bioscience job?
A bioscience job involves working in the field of biological sciences, often focusing on research, development, or application of biological knowledge in areas such as healthcare, pharmaceuticals, or biotechnology. These roles typically require knowledge of laboratory techniques, scientific analysis, and sometimes specialized certifications or degrees in biology or related fields.
What jobs can I do with biotechnology?
Prokidney professionals and others with biotechnology expertise can work in research and development, quality control, manufacturing, or regulatory roles within the biotech and healthcare industries. These jobs often require knowledge of laboratory techniques, data analysis, and sometimes specialized certifications or degrees in biology, biochemistry, or related fields.
More about Prokidney jobs
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What states have the most Prokidney jobs? States with the most job openings for Prokidney jobs include:
What job categories do people searching Prokidney jobs look for? The top searched job categories for Prokidney jobs are:
Full-time
Posted 9 days ago
Job description
The Team Lead, Cell Processing at ProKidney plays a critical role in leading advanced manufacturing operations, focusing on cell processing, aseptic processing, and ensuring compliance with cGMP guidelines. This role involves overseeing day-to-day operations of the manufacturing team, troubleshooting issues, leading deviation and CAPA investigations, and mentoring staff. The Team Lead is a Subject Matter Expert (SME) in manufacturing processes, driving continuous improvement, ensuring high-quality GMP documentation, and promoting operational efficiency.
Lead the day-to-day operations of the manufacturing team, ensuring all manufacturing processes are completed efficiently and effectively.
• Initiate manufacturing deviations, Corrective and Preventive Actions (CAPAs), and Critical Change Requests (CCRs) as required, leading investigations and compiling relevant data and information.
• Serve as a Subject Matter Expert (SME) on all manufacturing processes, providing guidance and training to team members.
• Quickly and efficiently troubleshoot manufacturing issues, directing team members on corrective actions.
• Complete manufacturing batch record reviews for all manufacturing processes, ensuring compliance with cGMP guidelines.
• Participate in the aseptic processing of in-house solutions and patient processes in accordance with cGMPs.
• Read, understand, and follow Standard Operating Procedures (SOPs) and assist in the development and revision of SOPs, batch records, and MS forms as needed.
• Assist in the selection, hiring, training, and mentoring of new staff, ensuring personnel are adequately trained and scheduled to support manufacturing operations.
• Perform routine transactions in the ERP system, including material requisitions, production tracking, work order updates, and managing production BOMs.
• Complete GMP documentation, including batch records, logbooks, and forms, according to Good Documentation Practices (GDP).
• Support the maintenance of the cleanroom environment, ensuring cleanliness and compliance with alert-level limits.
• Comply with all relevant safety policies, rules, and regulations, ensuring team members adhere to safety protocols.
• Perform procedures according to written guidelines, recognizing deviations from accepted practices, and taking corrective action as necessary.
• Lead and direct the work of others, with a wide degree of creativity and latitude expected. May provide consultation on projects and serve as a high-level contributor/specialist.
Secondary Responsibilities:
Minimum Qualifications:
ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.
Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.
Lead the day-to-day operations of the manufacturing team, ensuring all manufacturing processes are completed efficiently and effectively.
• Initiate manufacturing deviations, Corrective and Preventive Actions (CAPAs), and Critical Change Requests (CCRs) as required, leading investigations and compiling relevant data and information.
• Serve as a Subject Matter Expert (SME) on all manufacturing processes, providing guidance and training to team members.
• Quickly and efficiently troubleshoot manufacturing issues, directing team members on corrective actions.
• Complete manufacturing batch record reviews for all manufacturing processes, ensuring compliance with cGMP guidelines.
• Participate in the aseptic processing of in-house solutions and patient processes in accordance with cGMPs.
• Read, understand, and follow Standard Operating Procedures (SOPs) and assist in the development and revision of SOPs, batch records, and MS forms as needed.
• Assist in the selection, hiring, training, and mentoring of new staff, ensuring personnel are adequately trained and scheduled to support manufacturing operations.
• Perform routine transactions in the ERP system, including material requisitions, production tracking, work order updates, and managing production BOMs.
• Complete GMP documentation, including batch records, logbooks, and forms, according to Good Documentation Practices (GDP).
• Support the maintenance of the cleanroom environment, ensuring cleanliness and compliance with alert-level limits.
• Comply with all relevant safety policies, rules, and regulations, ensuring team members adhere to safety protocols.
• Perform procedures according to written guidelines, recognizing deviations from accepted practices, and taking corrective action as necessary.
• Lead and direct the work of others, with a wide degree of creativity and latitude expected. May provide consultation on projects and serve as a high-level contributor/specialist.
- Conduct aseptic manufacturing processes in a cleanroom environment, ensuring compliance with sterile techniques and regulatory standards.
Secondary Responsibilities:
- Participate in internal and external audits as required.
• Compile and analyze data, prepare reports, and make recommendations for process improvements.
• Perform routine logbook reviews and data tracking.
• Provide support for process development activities as needed.
• Perform other duties as assigned to support manufacturing operations effectively.
Minimum Qualifications:
- Education/Training: AS/BS in Biotechnology, Biology, Chemistry, or related field; a Science-related discipline preferred. High School Diploma or equivalent may be considered with significant relevant experience.
• Experience: Preferred minimum 4-6 years of relevant experience in cell processing, biotechnology manufacturing, or a related field, with 3-4 years of proven expertise in a cGMP-regulated environment.
• Skills/Abilities:
• Thorough knowledge of various biological processing techniques, including cell culture, relevant to ProKidney's cell therapy process. • Advanced knowledge of cGMP facilities and requirements.
• Proficiency in Microsoft applications, especially Word, Excel, etc.
• Strong organizational skills and the ability to manage and prioritize multiple projects or assignments, meeting deadlines effectively.
• Critical thinking and troubleshooting skills to handle unexpected events.
• Ability to exercise judgment within defined procedures and practices to determine appropriate actions.
• Other: Good eye/hand coordination, effective written and oral communication, a team-oriented approach, and a strong work ethic.
ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.
Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.
About ProKidney
Sourced by ZipRecruiter
Industry
Biotechnology research and development
Company size
51 - 200 Employees
Headquarters location
Winston-Salem, NC, US
Year founded
2019