CAREERS

Join us in developing pioneering therapies that will transform the medical landscape and change patients’ lives. Our technology regenerates diseased kidneys using a patient’s own cells and may prevent or delay dialysis or transplant.

QC Analyst I

Department:      Quality Control

Report to:           QC Manager

Status:                 Full Time/ Exempt

Position Summary:

The successful candidate will be responsible for performing routine quality control testing utilizing various biological and general laboratory techniques according to cGMP regulations. The position requires the utmost attention to detail, very strong organizational skills, computer proficiency, and a basic understanding of laboratory instrumentation. In addition, effective communication skills with minimal supervision are essential for success.

Requirements:

  • BS degree in the biological sciences or related field
  • 0-2 years relevant laboratory experience in a cGMP/FDA regulated industry
  • Demonstrated knowledge in the following laboratory techniques
    • Pipetting skills
    • Laboratory knowledge
    • Aseptic Techniques
  • Detail-oriented with strong written and verbal communication skills
  • Ability to problem-solve and troubleshoot as necessary

Qualified,interested candidates should send resume to: careers1@prokidney.com

Manufacturing Specialist

Department:      Manufacturing

Report to:           Manufacturing Manager

Status:                 Full Time/ Exempt

Position Summary:

The successful candidate will perform cell culture techniques, support mammalian cell culture manufacturing processes, operate various process equipment, and document daily manufacturing operations in a cGMP environment. Candidate will produce products by setting-up, cleaning, performing cell culture and following aseptic procedures. Additionally, the successful candidate will be responsible for maintaining a safe and clean work environment by following current good manufacturing practices (cGMP), and standard operating procedures.

Requirements:

  • AS/BS degree in biological sciences or related field
  • 0-2 years relevant cGMP biotechnology/pharmaceutical production experience
  • Demonstrated knowledge in the following laboratory techniques
    • Cell Culture
    • Aseptic Technique
    • Sterile Gowning
  • Experience following SOPs and execution of batch records
  • Computer skills including email, word and excel
  • Excellent attention to detail

Qualified, interested candidates should send resume to: careers2@prokidney.com

Biostatistician

Department:      Process Development

Report to:           Director of Process and Product Development

Status:                  Full Time/ Exempt

Position Summary:

  • Member of cross-functional teams who is effective in both independently and collaboratively in a flexible, fast-paced environment.
  • Contributes to trial design, protocol development, analysis planning, interpretation of results, and preparation of regulatory submissions.
  • Generates statistical models to improve methods of evaluating quantitative and qualitative data; identifying relationships and trends in data and factors affecting research results.
  • Prepares statistical analysis plans, including table shells.
  • Automates data extraction and data preprocessing tasks.
  • Provides ad hoc data driven analyses.
  • Works closely and collaboratively with members of clinical, process development, quality, finance, and others to meet corporate goals.
  • Position will be located in Winston-Salem, NC

Requirements:

  • Advanced degree in Statistics, Biostatistics, Mathematics, or related field. PhD. preferred.
  • Minimum of 5 years of industry experience, including design and analysis of clinical studies (cell therapies/biologics a plus).
  • Must have exceptional problem-solving and analytical abilities.
  • Must have strong statistical academic background, knowledge of quantitative methods including predictive modeling techniques.
  • Proficiency in SQL, JMP, SAS, R, Python or related data analysis languages required.
  • Preference for previous experience with study design and data analysis from a range of different phases of clinical development.
  • Must have excellent interpersonal, communication, writing and organizational skills.
  • Ability to evaluate moderately complex and variable issues with substantial potential impact, where development of an approach involves weighing various alternatives and balancing potentially conflicting situations using multiple sources of information.
  • Possess an open-minded approach and tolerance in applying statistical methods when dealing with novel analyses.
  • Must have excellent analytical skills in order to filter, prioritize and validate potentially complex and dynamic material from multiple sources.
  • Ability to manage multiple work assignments and establish priorities for a diverse range of tasks.
  • Flexibility to adapt quickly to the changing needs of the organization.

Qualified, interested candidates should send resume to: careers4@prokidney.com

QA Specialist I

Department:      Quality Assurance

Reports to:         Head of Quality

Status:                 Full Time/ Exempt

Position Summary:

The successful candidate will be responsible for implementing, tracking and monitoring company quality standards, procedures, systems and product manufacturing to ensure regulatory compliance.  The position requires the utmost attention to detail, very strong organizational skills, computer proficiency, and a basic understanding of quality requirements for a regulated industry.   In addition, effective communication and teamwork skills with minimal supervision are essential for success.

Requirements:

  • BS degree in the biological sciences or related field
  • 0-2 years relevant quality experience in a regulated industry
  • Detail-oriented with strong written and verbal communication skills
  • Ability to problem-solve and troubleshoot as necessary

Qualified,interested candidates should send resume to: careers3@prokidney.com

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