KBI Biopharma

KBI Biopharma

Manufacturing Supervisor (Nights)

USA - NC - Durham - Hamlin Rd

Sponsorship not specifiedDetected 91 days ago
Process ImprovementERPGMPCell 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

  • Solution Prep Manufacturing Supervisor 12 hour Night Shift 2*2*3 Schedule
  • The individual will plan, assign, and monitor daily tasks to ensure timely "Right First Time" execution and strict compliance with safety and quality regulations, e.g., current Good Manufacturing Practice (cGMP).
  • The Supervisor will review manufacturing procedures and instruct manufacturing personnel to ensure that manufacturing operations are conducted accurately, safely, and compliantly.

Responsibilities

  • Support daily production tasks to ensure schedule adherence while maintaining a successful and cGMP compliant execution.
  • Facilitate additional manufacturing activities and process support with other manufacturing groups, MS&T, PD, QA, Maintenance, Facilities, AFS and Microbiology.
  • Supervise, coach, mentor, and train team members to maintain educated, qualified, and motivated employees.
  • Ensure staff maintain a high level of compliance to procedures and quality expectations.
  • Drive process improvement initiatives; troubleshoot issues; track and trend metrics; and author, review, and approve manufacturing deviations, CAPAs, and change controls, as needed.
  • As needed, the Supervisor may also support core production operations (cell culture or purification), lead teams on projects to author standard operating procedures (SOPs) or batch and solution records
  • implement corrective and preventive actions (CAPAs)
  • support continuous improvement and other initiatives involving safety, quality, delivery, engagement, & cost in accordance to KBI/JSR business objectives.
  • A proven and qualified supervisor will use knowledge and experience to execute production operations, coach staff, troubleshoot, and continuously improve daily operations and/or manufacturing support operations.
  • The Supervisor will maintain a sense of ownership of the production processes, manufacturing environment and facility.

Requirements

  • Knowledge, Skills, Abilities Level Minimum Requirement Supervisor Bachelor's degree in a related scientific or engineering discipline and 4 years' experience in related cGMP manufacturing operations
  • or high school degree and 10 years' experience, or equivalent.
  • Excellent written and verbal communication skills are required.
  • Must be organized and able to focus in a face-paced, multi-tasked environment and maintain operational efficiency and positive demeanor.
  • Ability to write routine reports andcorrespondence.
  • Reasoning Ability 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.
  • Math Ability Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals.
  • Ability to compute rate, ratio, and percent and to draw and interpret graphs.

Nice to have

  • Demonstrated knowledge of mammalian cell culture (or microbial fermentation) or purification operations for production of biopharmaceuticals is preferred.
  • Experience in single-use platform technology is preferred.
  • Knowledge of quality systems and regulatory expectations is preferred.

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.
  • It is management's expectation that supervisors uphold the company's core competencies and departures from specifications and/or policies are reported according to KBI internal notification processes.
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This listing is sourced directly from KBI Biopharma's careers page and normalized into a canonical job model.