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Full-Time

Sr. Manager

Microbiology

Confirmed live in the last 24 hours

ProKidney

ProKidney

51-200 employees

Develops cell therapy for chronic kidney disease

Biotechnology
Healthcare

Senior

Winston-Salem, NC, USA

Category
Bioinformatics
Computational Biology
Genomics
Public Health
Biology Lab & Research
Biology & Biotech
Requirements
  • BS in Microbiology, Biology, or equivalent
  • 10+ years’ experience in a relevant field. Experience in a GMP setting and previous supervisory experience preferred.
  • Strong knowledge of GMP, FDA and EMA regulatory requirements applicable to Biologics and cell and gene therapy products.
  • Strong knowledge of current industry trends and can use the latest technologies.
  • Subject matter expert in quality control microbiology assays including sterility testing and endotoxin.
  • Subject matter expert in environmental monitoring.
  • Must have a thorough knowledge of cGMP facilities and cGMP requirements.
  • Computer software skills, organization, record keeping and planning skills, budget preparation, training skills, multiple projects, time management, facilitation skills are a plus.
  • Must have strong organizational skills and be able to manage and prioritize multiple projects or assignments at one time, including the ability to follow assignments through to completion and meet deadlines.
  • Ability to exercise judgment within defined procedures and practices to determine appropriate action.
  • Assure pragmatic problem solving is carried out with a strong sense of purpose and urgency and notify/make recommendations to Management regarding serious compliance or quality issues.
  • Proven logic and decision-making abilities, critical thinking skills. Aseptic practices and clean room operations.
Responsibilities
  • Manages the QC Microbiology testing programs and personnel.
  • Manages the Environmental Monitoring program for the clean rooms and manufacturing areas at ProKidney.
  • Manages day to day operations and weekly testing schedule.
  • Works with Product Development (PD) for the timely completion of required PD sample testing.
  • Reviews and approves QC testing forms.
  • Responsible for changing the status of appropriate Class I raw materials in SAGE and miscellaneous issuing of raw materials for testing.
  • Subject matter expert of relevant QC Microbiology assays and EM.
  • Qualified to perform all QC assays and help with trouble shooting as required.
  • Responsible for overall cGMP compliance of the department and may represent QC on project teams or during external audits and inspections.
  • Must have experience in writing technical documents and protocols.
  • Able to clearly communicate problems and observations with management from other departments.
  • Deliver to Plan: Lead and direct the safety, quality, and daily operation in QC. Oversee all tasks in the lab and clean rooms as they are carried out.
  • Maintain a good working relation with other departments.
  • Monitor and coach staff to ensure full compliance with GMP and Quality system requirements. Responsible for overall inspection readiness and compliance with quality requirements.
  • Lead and oversee the on-time completion of document review for completeness, clarity, accuracy to support on-time release of clinical lots.
  • Adapts departmental plans and priorities to address resource and operational challenges.
  • Excellent verbal and written communication skills.
  • Ensure that the quality control labs are well maintained and inspection ready at all times.
  • Coach, teach, train, and develop employees through 1:1 meetings.
  • Maintain individual training plan and ensure team remains up to date with training readiness. Strong business acumen to manage diverse teams.
  • Perform other duties as assigned.

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 many patients currently rely on. ProKidney is in the late stages of clinical trials, and early results indicate that rilparencel may effectively maintain kidney function. Unlike other treatments, ProKidney specifically targets CKD, a condition affecting over 35 million adults in the U.S., and aims to fill a significant gap in available therapies. The company's goal is to provide a groundbreaking treatment that improves the quality of life for CKD patients and reduces their reliance on dialysis.

Company Stage

IPO

Total Funding

$559.3M

Headquarters

Winston-Salem, North Carolina

Founded

N/A

Growth & Insights
Headcount

6 month growth

14%

1 year growth

35%

2 year growth

87%
Simplify Jobs

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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