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KBI Biopharma, Inc.

Manufacturing Assistant

Durham, NC · On-site

$16.50 - $21.25/hr

At KBI Biopharma, we are advancing science and accelerating breakthroughs. As a global leader in biopharmaceutical development and manufacturing, we empower life science companies to bring new ...

KBI Biopharma, Inc.

Manufacturing Assistant

Durham, NC · On-site

$16.50 - $21.25/hr

At KBI Biopharma, we are advancing science and accelerating breakthroughs. As a global leader in biopharmaceutical development and manufacturing, we empower life science companies to bring new ...

KBI Biopharma, Inc.

QA Specialist II

Durham, NC

Any employee entering a KBI site located in the US must inform KBI Biopharma of their vaccination status and must submit their vaccination status. All vaccinated employees are required to provide ...

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KBI stands for Kansas Bureau of Investigation. KBI agents are law enforcement officers employed by the state of Kansas to investigate and solve major crimes, such as homicides, drug offenses, and public corruption. They work closely with local police departments, sheriffs, and prosecutors to provide specialized investigative expertise. KBI agents also assist with forensic analysis, crime scene processing, and criminal intelligence gathering throughout the state.

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One common challenge for Knowledge-Based Interviewers (KBI) is ensuring that their questions accurately assess both theoretical knowledge and real-world application relevant to the role. Balancing objectivity with a conversational tone can also be difficult, as it's important to make candidates feel comfortable while still maintaining rigorous evaluation standards. Additionally, interviewers must stay updated on industry trends to tailor their assessments appropriately and avoid outdated questions. Collaborative debriefs with hiring teams are essential to ensure fair and consistent candidate evaluations.

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To thrive as a Knowledge-Based Inspector (KBI), you need a strong understanding of industry-specific regulations, analytical skills, and attention to detail, often supported by relevant certifications or degrees. Familiarity with inspection software, data collection tools, and reporting systems is typically required. Critical thinking, effective communication, and integrity are essential soft skills that set top performers apart. These abilities ensure thorough inspections, regulatory compliance, and trustworthy reporting, which are crucial for safety and operational excellence.
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Infographic showing various Kbi job openings in the United States as of August 2026, with employment types broken down into 91% Full Time, and 9% Part Time. Highlights an 99% Physical, and 1% Remote job distribution, with an average salary of $44,814 per year, or $21.5 per hour.

KBI: US - Downstream Process Development Scientist II

KBI Biopharma, Inc.

Boulder, CO • On-site

$106K - $146K/yr

Full-time

Re-posted 11 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

JOB SUMMARY
The Downstream Process Development (PD) Scientist II provides process development ownership for a product, including all development and design decisions, with some oversight and supervision from senior process development staff. They can apply advanced scientific principles to design and execute laboratory studies for unit operation development and optimization, and solve problems of increasing scope and complexity. They possess a strong working knowledge of the downstream functional area with strong aptitude in chromatography and tangential flow filtration, and a developing understanding of phase-appropriate practices and expectations. They author and review technical documents including protocols and reports commensurate with PD compliance and quality standards. This workflow encompasses process development scope as well as support of technology transfer activities in preparation for cGMP production. The PD Scientist II is responsible for maintaining training compliance, according to site expectations. This is a salaried exempt position, with the expectation to cover shift work as needed to support laboratory activities and organizational need.
Responsibilities
  • Executes process development, process characterization, and technology transfer of microbial processes to commercial cGMP facility.
  • Works toward developing a broad knowledge of state-of-the-art principles and theory.
  • Responsible for producing high quality documentation and client reports suitable for publication and regulatory requirements. Compiles and presents data to clients.
  • Supports downstream process development efforts in the laboratory and manufacturing areas. Executes experiments with some oversight. Conceptualizes and proposes process development and manufacturing based on process data. Execution includes downstream unit operations such as chromatography, tangential flow filtration, normal filtration, as well as sampling and basic analysis of process samples; concentration, pH, and conductivity.
  • Will lead the downstream portion of development, process characterization, and/or technology transfer programs, acting as subject matter expert (SME), and directing the efforts of the team in meeting the project deliverables.
  • Provide technical support for cGMP manufacturing through floor coverage, batch document review, and support of deviations and change controls with some oversight.
  • Responsible for developing/maintaining a current understanding of cGMP and other regulatory requirements.
  • Adheres to all safety requirements and assures that departmental employees comply with required safety procedures.
  • Conceptualizes, proposes and executes 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.

REQUIREMENTS
B.S. degree and a minimum of 6+ years of related experience; M.S. and 4+ years of related experience or Ph.D. and 1+ years related experience in a scientific discipline.
Experience with downstream process development and chromatography equipment required. Excellent written and verbal communication skills, focus on customer service, and ability to meet strict client deadlines. Highly collaborative. Flexibility of hours to support downstream processes. Knowledge of GMPs and biotechnology-derived product regulations preferred.
Salary: $106,480-$146,410
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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