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Downstream Process Development Jobs in North Carolina

KBI Biopharma, Inc.

Senior Director, MS&T

Durham, NC · On-site

$180 - $240/hr

Must have demonstrated biologics expertise in upstream or downstream processing and operations Must have experience in collaborating with process development, quality, supply chain, engineering and ...

KBI Biopharma, Inc.

Senior Director, MS&T

Durham, NC · On-site

Must have demonstrated biologics expertise in upstream or downstream processing and operations * Must have experience in collaborating with process development, quality, supply chain, engineering and ...

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Downstream Process Development information

What is downstream process development?

A Downstream Process Development job involves optimizing and scaling purification processes for biologics, such as proteins, antibodies, or gene therapies. Scientists and engineers in this role develop efficient methods for isolation, purification, and formulation of therapeutic products while ensuring quality and regulatory compliance. Key activities include chromatography, filtration, and process analytics to improve yield, purity, and consistency. This role is critical in biotech and pharmaceutical industries to ensure safe and effective drug production for clinical and commercial use.

What does someone in downstream process development do?

Professionals in Downstream Process Development are typically responsible for designing, optimizing, and scaling up purification processes for biopharmaceutical products. Their day-to-day work may involve conducting laboratory experiments, analyzing data, troubleshooting technical issues, and documenting process changes in accordance with regulatory standards. They also frequently collaborate with upstream processing, analytical, and quality teams to ensure seamless transfer and integration of processes. The role often includes participating in project meetings, contributing to process validation efforts, and supporting technology transfer to manufacturing teams, making it both technically challenging and collaborative.

What are the key skills and qualifications needed for downstream process development?

To excel in Downstream Process Development, you generally need a strong background in biochemistry, chemical engineering, or a related life sciences field, often with experience in bioprocessing or purification technologies. Familiarity with chromatography systems, filtration equipment, process analytical technology (PAT), and relevant software such as DeltaV or Unicorn is frequently required, along with knowledge of GMP and regulatory standards. Excellent problem-solving, project management, and cross-functional communication skills help professionals succeed in dynamic team environments. These competencies are crucial for developing efficient, scalable purification processes that ensure high product quality and support organizational goals.

What are the most commonly searched types of Downstream Process Development jobs in North Carolina?

The most popular types of Downstream Process Development jobs in North Carolina are:

What job categories do people searching Downstream Process Development jobs in North Carolina look for?

The top searched job categories for Downstream Process Development jobs in North Carolina are:

What cities in North Carolina are hiring for Downstream Process Development jobs?

Cities in North Carolina with the most Downstream Process Development job openings:

Downstream Process Development jobs near you
Infographic showing various Downstream Process Development job openings in North Carolina as of August 2026, with employment types broken down into 1% As Needed, 79% Full Time, 11% Part Time, 7% Temporary, and 2% Contract. Highlights an 89% Physical, 3% Hybrid, and 8% Remote job distribution.

Process Development Associate II

KBI Biopharma, Inc.

Durham, NC • On-site

Full-time

Posted 15 days ago

KBI Biopharma rating

6.5

Company rating: 6.5 out of 10

Based on 6 frontline employees who took The Breakroom Quiz

Job description

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.

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