Full-Time
QC Analyst 2
Confirmed live in the last 24 hours
ProKidney
51-200 employees
Develops cell therapy for chronic kidney disease
Senior
Winston-Salem, NC, USA
- BS in Microbiology, Biology, Chemistry, or equivalent required Preferred area of study: Science related discipline
- Minimum 5+ years relevant experience
- Ability to exercise judgment within defined procedures and practices to determine appropriate action.
- Ability to read, understand and follow schedule.
- Ability to read, understand and follow SOP’s.
- Ability to understand the importance of compliance with cGMP’s.
- Ability to follow GLP daily.
- Ability to work independently as well as in a team setting.
- Computer software skills including Microsoft Office
- Organization skills, record keeping, time management, regular attendance
- Good eye/hand coordination
- Written and oral communication, team oriented, strong work ethic
- Supports the weekly environmental monitoring and post sampling incubation and enumeration of plates.
- Reads, understands, and follows Standard Operating Procedures (SOPs)
- Assists in the training and mentoring of new staff.
- Sets up and operates quality control equipment including cell counters, centrifuges analytical balances and coordinates the maintenance of these equipment with the facility personnel.
- Assists in deviation and OOL investigations, and compiles data/information related to internal investigations as required.
- Revises approved documents as required including SOPs, testing forms, and MS forms and reviews document updates for accuracy and completeness.
- Perform routine transactions with the ERP system including, but not limited to material requisitions and submission of PR’s for outside testing labs.
- Responsible for follow-ups with the outside testing labs regarding delay in availability of test reports or any other issues with sample submissions.
- Complete GMP documentation, including testing forms, logbooks according to GDP
- Is knowledgeable and complies with all pertinent safety policies, rules and regulations.
- Ensure that all team members comply with safety rules and regulations.
- Able to perform procedures according to written guidelines and recognize a deviation from accepted practice.
- Relies on instructions and pre-established guidelines to perform the functions of the job.
ProKidney focuses on treating Chronic Kidney Disease (CKD) through a novel cell therapy called rilparencel. This therapy aims to preserve kidney function in patients with advanced CKD, potentially delaying or eliminating the need for dialysis, which is often the only option for these patients. ProKidney is currently in the late stages of clinical trials, with early data indicating that rilparencel could effectively maintain kidney function. Unlike many competitors, ProKidney specifically targets the CKD market, which affects over 35 million adults in the U.S., and aims to fill a critical gap in treatment options. The company's goal is to provide a groundbreaking alternative to dialysis, significantly improving the quality of life for CKD patients.
Company Stage
IPO
Total Funding
$559.3M
Headquarters
Winston-Salem, North Carolina
Founded
N/A
6 month growth
↑ 22%1 year growth
↑ 44%2 year growth
↑ 101%
Simplify's Take
What believers are saying
- Successful $140 million public and direct offering boosts financial stability and supports ongoing R&D efforts.
- The potential approval and commercialization of rilparencel could revolutionize CKD treatment and significantly improve patient quality of life.
- Expansion plans, including a new facility in Greensboro, promise job creation and economic growth.
What critics are saying
- The biotech sector's inherent volatility, as evidenced by ProKidney's significant stock price fluctuations, could impact financial stability.
- Dependence on the successful approval and commercialization of rilparencel means any regulatory setbacks could severely affect the company's prospects.
What makes ProKidney unique
- ProKidney is pioneering a novel cell therapy, rilparencel, specifically targeting CKD, unlike many competitors who focus on broader therapeutic areas.
- Their focus on delaying or eliminating the need for dialysis offers a unique value proposition in the CKD treatment landscape.
- ProKidney's late-stage clinical trials and promising early data position it as a frontrunner in CKD cell therapy innovation.
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