Process Development Associate II

Posted Yesterday
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Durham, NC, USA
In-Office
Junior
Biotech
The Role
Execute downstream process development lab experiments (chromatography, TFF, clarification, filtration), perform basic sample analyses, document results, troubleshoot experiments, support technical documentation and client interactions, and maintain lab safety and compliance.
Summary Generated by Built In

Position Summary:

The Downstream Process Development Associate II supports and executes laboratory studies within the KBI Biopharma (KBI) Downstream Process Development organization under general supervision.

Position Responsibilities:

  • Conducts laboratory experiments in support of downstream/drug substance process development including preparing solutions, running downstream unit operations (chromatography, tangential flow filtration, clarification, normal filtration, etc.), sampling and executing basic analysis of process samples (concentration, pH, conductivity, etc.).
  • Exercises judgment within defined procedures and practices to determine appropriate action (sometimes called upon to exercise judgment outside of defined procedures).
  • Observes and analyzes data resulting from executed experiments; identifies and troubleshoots unexpected results with input and/or review from peers or management.
  • Compiles data and contributes to drafting of templated technical documents. May contribute to client presentation development and may interact with clients.
  • May contribute to the evaluation, development and implementation of new downstream technologies leading to process improvements and efficiency of operation in support of downstream process development and manufacturing activities.
  • Documents procedures, observations, and results in laboratory notebooks and responsible for maintaining training compliance, according to site expectation. Reviews documentation and records as assigned.
  • Contributes to general lab maintenance and operation excellence initiatives in accordance with internal guidance. Assures proper labeling, handling, and storage of all chemicals used in the area; assures proper labeling and disposition of hazardous waste in satellite areas; adheres to all safety requirements and follows safe procedures, and attends all required safety and health training, including handling hazardous waste.
  • Reacts to change productively and handles other essential tasks as assigned.

Minimum Requirements:

  • Process Development Associate II requires a B.S. degree and 2+ years experience or a M.S. degree.
  • Excellent written and verbal communication skills, focus on customer service, and ability to meet strict client deadlines. Flexibility of hours to support downstream processes. Knowledge of GMPs and biotechnology-derived product regulations preferred.

KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.

I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary.

I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.

Skills Required

  • B.S. degree plus 2+ years experience, or M.S. degree
  • Experience conducting downstream unit operations (chromatography, tangential flow filtration, clarification, filtration) and basic sample analysis (concentration, pH, conductivity)
  • Excellent written and verbal communication skills
  • Customer service focus and ability to meet strict client deadlines
  • Flexibility of hours to support downstream processes
  • Maintain training compliance and complete required safety and hazardous waste handling training
  • Knowledge of GMPs and biotechnology-derived product regulations

KBI Biopharma Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about KBI Biopharma and has not been reviewed or approved by KBI Biopharma.

  • Healthcare Strength Health coverage includes medical, dental, and vision with HSA/FSA options, alongside life and disability insurance. Employer-verified listings indicate solid foundational coverage across sites.
  • Leave & Time Off Breadth PTO and paid holidays are provided, with flexible or “unlimited” PTO available in some salaried roles and standard accrual with limited rollover elsewhere. This breadth supports time away options across job families.
  • Parental & Family Support Parental leave is available, with indications of 12 weeks for U.S. employees in recent materials. Maternity and paternity leave are included as part of the package.

KBI Biopharma Insights

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The Company
HQ: Durham, NC
1,282 Employees
Year Founded: 1996

What We Do

KBI Biopharma is an award-winning biopharmaceutical contract services organization providing fully-integrated, accelerated drug development and biomanufacturing services to pharmaceutical and biotechnology companies globally. With each of our 500+ client partners, we have worked closely to personalize and rapidly accelerate their drug development programs. Built upon a foundation of world-class analytical capabilities, we deliver efficient process development and clinical and commercial cGMP manufacturing services for mammalian, microbial, and cell therapy programs. KBI is proud to be a JSR Life Sciences Company.

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