KBI Biopharma

KBI Biopharma

Manufacturing Associate I/II- Upstream

USA - NC - Durham - National Way · Mid

Sponsorship not specifiedDetected 79 days ago
Supply ChainERPGMPCell CultureCommunicationMicrosoft OfficeFermentationGxP

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Cap-exempt (no lottery)0
Sponsors this role80
Entry-level history0
PERM / green-card track0
Lottery odds40
Fits your clock70

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About the role

  • This position is on a 2-2-3 rotating schedule, dayshift (7am-7pm)
  • The Manufacturing Associate I/II is responsible for performing upstream processing for biopharmaceutical products.
  • The Manufacturing Associate must follow written, approved procedures and forms to ensure all work is conducted "Right First Time" (RFT) following Good Manufacturing Practice (GMP), including good documentation practices, and/or Good Laboratory Practice (GLP).

Responsibilities

  • Perform operations in a cleanroom environment, applying controls to ensure aseptic processing including gowning and cleaning procedures.
  • Document each task involving manufacturing records and logbooks following GDP at the time of execution.
  • Utilize and perform maintenance on equipment per applicable SOP.
  • The Manufacturing Associate will execute daily tasks and maintain strict accordance with manufacturing records, SOPs, and GMP.
  • Staff will maintain a sense of ownership of the production processes, the manufacturing environment, and the facility.

Requirements

  • Bachelor's degree in a related scientific or engineering discipline and 0-2 years' experience in related cGMP manufacturing operations
  • or high school degree and 3-5 years' experience, or equivalent.
  • Bachelor's degree in a related scientific or engineering discipline and 2-5 years' experience in related cGMP manufacturing operations
  • or high school degree and 4-6 years' experience, or equivalent.
  • Excellent written and verbal communication skills are required.
  • Ability to write routine reports and correspondence.
  • Ability to speak effectively to groups.
  • Manufacturing Associate I: Bachelor's degree in a related scientific or engineering discipline and 0-2 years' experience in related cGMP manufacturing operations
  • Manufacturing Associate II: Bachelor's degree in a related scientific or engineering discipline and 2-5 years' experience in related cGMP manufacturing operations

Nice to have

  • Basic knowledge of upstream (cell culture or fermentation) unit operations is preferred.
  • Experience in single-use platform technology is preferred.

Benefits

  • 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.

Company info

  • 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.
  • Manufacture bulk intermediates and drug substances per manufacturing batch records and in compliance with quality standards, company policies and current regulations.

Equal opportunity

  • KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force.
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This listing is sourced directly from KBI Biopharma's careers page and normalized into a canonical job model.