Manufacturing Lead: 24/7 CGMP Ops & Mentorship

FUJIFILM Biotechnologies

Milwaukee (WI)

Sur place

USD 90 000 - 130 000

Plein temps

14 jours+

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Résumé du poste

FUJIFILM Biotechnologies in North Carolina seeks a Manufacturing Lead to drive CGMP manufacturing operations, ensure SOP compliance, and mentor junior staff.

Responsibilities include leading processing steps, in-process sampling, validation, shift support, and continuous improvement while maintaining safety and quality standards. This role requires strong collaboration across teams and flexibility for 24/7 operation.

Qualifications

  • 8+ years of CGMP manufacturing experience or equivalent with HS diploma
  • 6+ years with an Associate’s in life sciences
  • 4+ years with a Bachelor’s in life sciences

Responsabilités

  • Adheres to safety protocols and fosters a safety culture on the manufacturing floor
  • Leads, executes, and documents manufacturing steps and monitoring per SOPs and CGMP
  • Oversees in-process sampling and testing (e.g., pH, conductivity, visual checks)
  • Executes validation protocols and backs up supervisor/manager when needed
  • Trains and mentors junior associates to enhance team capability
  • Supports daily scheduling on the manufacturing floor and acts as back-up for supervisor
  • Leads troubleshooting for operational issues
  • Supports shift huddles, escalations, investigations, and CI projects
  • Serves as SME for at least two core manufacturing responsibilities
  • Maintains training to perform required activities
  • Performs other duties as assigned

Connaissances

CGMP manufacturing
SOP adherence
Process monitoring
Training & mentoring
Safety culture

Formation

Bachelor’s degree in life science
Associate’s degree in life science
High School Diploma/GED with CGMP experience

Description du poste

FUJIFILM Biotechnologies in North Carolina seeks a Manufacturing Lead to drive CGMP manufacturing operations, ensure SOP compliance, and mentor junior staff.

Responsibilities include leading processing steps, in-process sampling, validation, shift support, and continuous improvement while maintaining safety and quality standards. This role requires strong collaboration across teams and flexibility for 24/7 operation.

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