Full-Time
QC Analyst 2
Posted on 1/16/2025
ProKidney
51-200 employees
Develops cell therapy for chronic kidney disease
Senior
Winston-Salem, NC, USA
- BS in Microbiology, Biology, Chemistry, or equivalent required
- 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
- Preferred area of study: Science related discipline
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 many patients. ProKidney targets a significant healthcare issue, as over 35 million adults in the U.S. are affected by CKD, with around 135,000 progressing to dialysis each year. The company is in the late stages of clinical trials for rilparencel, which has shown promise in preserving kidney function. Unlike competitors, ProKidney is dedicated specifically to CKD and is developing a unique treatment that addresses a critical gap in the market. The goal is to provide a viable alternative to dialysis, improving the quality of life for CKD patients.
Company Stage
IPO
Total Funding
$559.3M
Headquarters
Winston-Salem, North Carolina
Founded
2015
6 month growth
↑ 1%1 year growth
↑ 0%2 year growth
↓ -1%
Simplify's Take
What believers are saying
- ProKidney raised $140 million, boosting clinical trials and R&D for rilparencel.
- The FDA's approval of similar therapies may ease rilparencel's regulatory pathway.
- Growing personalized medicine trends favor ProKidney's cell therapy approach.
What critics are saying
- ProKidney's canceled Greensboro expansion may harm its reputation and stakeholder trust.
- Increased manufacturing expenses could strain financial resources, affecting development pace.
- Reliance on public offerings for capital may indicate potential cash flow issues.
What makes ProKidney unique
- ProKidney is pioneering rilparencel, a novel cell therapy for CKD.
- Rilparencel aims to delay or eliminate the need for dialysis in CKD patients.
- ProKidney targets an underserved CKD market, addressing a critical treatment gap.
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