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Production Operations Lead – Pharmaceutical Manufacturing

Job in Aurora, Kane County, Illinois, 60505, USA
Listing for: SoTalent
Full Time position
Listed on 2026-06-14
Job specializations:
  • Manufacturing / Production
    Production Manager, Pharmaceutical Manufacturing, Manufacturing Engineer, Operations Engineer
Salary/Wage Range or Industry Benchmark: 60000 USD Yearly USD 60000.00 YEAR
Job Description & How to Apply Below

Production Operations Group Lead (Day Shift) – Biopharmaceutical Manufacturing

About the Role

We are seeking a Production Operations Group Lead to oversee critical manufacturing operations within a regulated biopharmaceutical production environment
. This role leads day-to-day activities across inspection, pasteurization, and incubation processes, ensuring safe, efficient, and compliant production of high-quality pharmaceutical products.

You will report to manufacturing leadership and play a key role in driving operational excellence, compliance, and continuous improvement in a fast-paced GMP environment.

Key Responsibilities

  • Lead and supervise daily production operations across assigned manufacturing areas
  • Ensure compliance with cGMP, EHS, FDA, and internal quality standards
  • Monitor production schedules, staffing, materials, and equipment utilization
  • Review and approve batch records and ensure accurate documentation for product release
  • Support deviation investigations, troubleshooting, and resolution of manufacturing issues
  • Drive continuous improvement and lean manufacturing initiatives
  • Conduct daily operational walkthroughs (Gemba) to reinforce safety and quality culture
  • Support training, onboarding, and performance development of production staff
  • Participate in audits and regulatory inspections as needed (including FDA readiness)
  • Collaborate cross-functionally with Quality, Engineering, and Supply Chain teams

What We’re Looking For

  • High school diploma/GED with 5+ years of manufacturing experience OR
  • Bachelor’s degree in Science, Engineering, or related field with 2+ years of experience
  • Experience in pharmaceutical, biotech, or regulated manufacturing environments preferred
  • Strong understanding of GMP / FDA-regulated production environments
  • Leadership experience in a production or operations setting
  • Strong communication, teamwork, and problem-solving skills
  • Proficiency in MS Office (Word, Excel) and production documentation systems
  • Ability to work in controlled environments (clean rooms) and shift-based schedules

Preferred Experience

  • Lean manufacturing / continuous improvement exposure
  • Experience in batch manufacturing or biologics production
  • Prior supervisory or team lead experience in operations
  • Exposure to FDA inspections or regulated audits
  • GMP-regulated manufacturing facility
  • Cleanroom and controlled production areas
  • Physically active role involving standing, walking, and handling production equipment

Why This Role

This is an opportunity to take a leadership role in a mission-driven pharmaceutical manufacturing environment
, ensuring patients receive safe, high-quality therapies while driving operational efficiency and continuous improvement.

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