Back to jobs

Senior ASAT Scientist

Winston-Salem, North Carolina, United States

Position Summary:
The Senior Scientist will serve as a technical leader within the Analytical Science and Technology (ASAT) team, part of the CMC Development organization. This role is responsible for independently designing and executing analytical strategies to support late-stage product development, method lifecycle management, and technology transfer for biologics and cell/gene therapy products. The incumbent will act as a key subject matter expert (SME) in analytical method development, qualification, validation, and troubleshooting, collaborating cross-functionally with Process Development, MSAT, Quality Control, and Regulatory Affairs. The primary location for this role is Morrisville location, however this role will require travel to the Winston Salem location for the meetings, troubleshooting methods, and method validation activities.

Essential Duties & Responsibilities:

  • Develop and optimize bio-analytical methods in support of product development and technology transfer activities.
  • Design, execute and interpret experiments to support product development and tech transfer activities.
  • Design and execute method validation and method transfer protocols.
  • Author scientific/technical protocols, reports and test methods in support of product commercialization.
  • Act as a primary Subject Matter Expertise (SME) for method troubleshooting and OOS investigation occurred during release and/or stability testing
  • Provide SME assessment for deviation, CAPA and change control.
  • Provide analytical expertise during internal audits, regulatory inspections, and cross-functional reviews.
  • Perform data trending analysis, assay monitoring.
  • Collaborate closely with Process Development, MSAT, Quality, and Regulatory to align on analytical strategies throughout the product lifecycle.
  • Mentor junior scientists and provide peer review support for technical documents.
  • Participate in internal and external meetings, including presentation of the data and projects.

Qualifications:

  • Education/Training:
    • D. in Analytical Chemistry, Biochemistry, Molecular Biology, or related field with 10+ years of relevant industry experience, or Master’s degree with 15+ years of experience.
  • Experience:
    • Must have 3+ years of GMP experience and technical proficiency supporting method development/validation.
    • Hands-on experience with flow cytometry, ELISA, and In-depth knowledge of molecular and/or cell biology is required.
    • Prior experience with conducting method development, method transfer, and method validation with an understanding of the analytical method lifecycle is required.
    • Experience in Gene and/or Cell therapy is desirable.
    • Experience with analytical support for late-stage or commercial biological products and cGMP manufacturing.
    • Experience of using JMP or similar statistical tools is a plus
  • Knowledge:
    • In-depth knowledge of ICH and FDA method validation guidelines, including phase appropriate strategies.
  • Skills:
    • Ability to solve problems, manage priorities and maintain aggressive timelines while maintaining flexibility and efficiency.
    • Good written and verbal communication skills.
    • Excellent technical writing skills are essential.
    • Demonstrated collaboration skills with cross-functional teams.  
    • Must have a high level of independence and attention to detail

ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.

Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.

Create a Job Alert

Interested in building your career at ProKidney? Get future opportunities sent straight to your email.

Apply for this job

*

indicates a required field

Resume/CV*

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

Education

Select...
Select...
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.