Back to jobs

Process Development Research Associate 2

Winston-Salem, North Carolina, United States

Join us in developing pioneering therapies that aim to transform the treatment of CKD and change patients’ lives. Our technology is designed to treat diseased kidneys using a patient’s own cells and may prevent or delay dialysis or transplant.

Prokidney is seeking an experienced Research Associate 2 for our Cell Therapy Process Development team. The ideal candidate will have a strong background in cell therapy or biopharmaceutical development, process optimization, and technology transfer. In this role, you will lead or support the development and improvement of cell therapy manufacturing processes, contributing to the advancement of cutting-edge therapies. This is a great opportunity for individuals who are passionate about making an impact in the evolving field of cell therapy.

Key Responsibilities:

  • Design and execution of experiments to optimize and improve processes for cell therapy manufacturing, including but not limited to media preparation, cell expansion and harvest, and product formulation. Analyze experimental data and present results in a clear and actionable manner to stakeholders.
  • Provide technical expertise in the development and implementation new techniques and technologies. Support troubleshooting and process improvement initiatives.
  • Work closely with cross-functional teams, including Quality Assurance, Regulatory Affairs, and Manufacturing, to ensure the successful transfer of process into GMP clinical and commercial manufacturing.
  • Support the characterization and validation of cell therapy processes, ensuring compliance with regulatory guidelines and internal standards. Conduct process performance qualification (PPQ) studies and support clinical trial material production.
  • Ensure that all process development activities adhere to GMP and applicable regulatory standards. Support regulatory filings and audits as needed.
  • Preparation and review of technical documentation, including process development reports, batch records, SOPs (Standard Operating Procedures), and change controls.
  • Assist to identify potential risks in process development and manufacturing and implement strategies for mitigation, ensuring the successful advancement of cell therapy programs.

Qualifications:

  • Bachelor's or Master's degree in Cell Biology, Biotechnology, Biochemical Engineering, or a related field.
  • 3 plus years of experience in cell therapy and /or biopharmaceutical process development. Ability in execution and troubleshooting experiments, analyzing/ reporting/presenting data. Experience in aseptic techniques is essential.
  • Demonstrated ability to effectively work in cross functional teams, meet deadlines, and prioritize multiple projects.
  • Strong problem-solving abilities, critical thinking, and the ability to collaborate with cross-functional teams. Strong verbal and written communication skills, including technical writing.
  • Understanding of GMP, GLP, and regulatory requirements for the development of cell-based therapies. Experience with regulatory submissions and support for inspections is a plus.
  • Demonstrated troubleshooting and problem-solving skills.
  • Understanding of basic statistics and working knowledge of statistical software (e.g. JMP).
  • Must be comfortable handling human tissues.
  • There will be occasional weekend work.

ProKidney is an Equal Opportunity Employer. All applicants are considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. We are committed to the principles of equal employment opportunity for all employees with a work environment free of discrimination and harassment. 

Apply for this job

*

indicates a required field

Resume/CV*

Accepted file types: pdf, doc, docx, txt, rtf


Select...
Select...

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey. Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file.

As set forth in ProKidney’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law.

Select...
Select...
Race & Ethnicity Definitions

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.

Select...

Voluntary Self-Identification of Disability

Form CC-305
Page 1 of 1
OMB Control Number 1250-0005
Expires 04/30/2026

Why are you being asked to complete this form?

We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years.

Completing this form is voluntary, and we hope that you will choose to do so. Your answer is confidential. No one who makes hiring decisions will see it. Your decision to complete the form and your answer will not harm you in any way. If you want to learn more about the law or this form, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

How do you know if you have a disability?

A disability is a condition that substantially limits one or more of your “major life activities.” If you have or have ever had such a condition, you are a person with a disability. Disabilities include, but are not limited to:

  • Alcohol or other substance use disorder (not currently using drugs illegally)
  • Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, HIV/AIDS
  • Blind or low vision
  • Cancer (past or present)
  • Cardiovascular or heart disease
  • Celiac disease
  • Cerebral palsy
  • Deaf or serious difficulty hearing
  • Diabetes
  • Disfigurement, for example, disfigurement caused by burns, wounds, accidents, or congenital disorders
  • Epilepsy or other seizure disorder
  • Gastrointestinal disorders, for example, Crohn's Disease, irritable bowel syndrome
  • Intellectual or developmental disability
  • Mental health conditions, for example, depression, bipolar disorder, anxiety disorder, schizophrenia, PTSD
  • Missing limbs or partially missing limbs
  • Mobility impairment, benefiting from the use of a wheelchair, scooter, walker, leg brace(s) and/or other supports
  • Nervous system condition, for example, migraine headaches, Parkinson’s disease, multiple sclerosis (MS)
  • Neurodivergence, for example, attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilities
  • Partial or complete paralysis (any cause)
  • Pulmonary or respiratory conditions, for example, tuberculosis, asthma, emphysema
  • Short stature (dwarfism)
  • Traumatic brain injury
Select...

PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.