KBI Biopharma

KBI Biopharma

Manufacturing Associate I/II (Nights) - Downstream

USA - NC - Durham - Hamlin Rd · Mid

Sponsorship not specifiedDetected 76 days ago
Supply ChainERPGMPCell CultureCommunicationMicrosoft OfficeFermentationGxP

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About the role

  • Nightshift: 7PM-7AM, 2-2-3 rotating schedule
  • The Senior Manufacturing Associate I/II (Nights) is responsible for performing upstream or downstream processing of bulk intermediates and/or bulk drug substances for biopharmaceutical products.
  • 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.
  • Staff will maintain a sense of ownership of the production processes, the manufacturing environment, and the facility.
  • Manufacturing Associate will execute daily tasks and maintain strict accordance with manufacturing records, SOPs, and GMP with minimal supervision and effectively communicate with the manufacturing supervisor and support groups.

Requirements

  • Bachelor's degree in a related scientific or engineering discipline with 4-6 years' experience in related GMP manufacturing operations
  • or high school degree with 7-10 years' experience in related GMP manufacturing operations.
  • Bachelor's degree in a related scientific or engineering discipline with 5+ years' experience in related GMP manufacturing operations
  • or high school degree with 10+ years' experience in related GMP manufacturing operations.
  • Ability to write routine reports and correspondence.
  • Ability to speak effectively to groups.
  • Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
  • Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

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.