Sr. Supervisor, Manufacturing - Small Scale Purification (Days)

BiogenResearch Triangle Park, NC
Onsite

About The Position

Our factories run 24/7 operations. Our manufacturing teams work 12-hour shifts (either Days or Nights) on a 2-2-3 calendar rotation. Shift Details : This role follows a 2-2-3 calendar rotation on days (6:00 AM – 6:00 PM ET) Internal Shift Details: Black Day rotating schedule We are seeking a Supervisor to lead day shift operations supporting drug substance manufacturing under cGMP conditions. This role oversees Manufacturing Associates, ensures compliant execution of production activities, and drives a culture of safety, quality, and continuous improvement. You will play a key role in coordinating cross-functional activities and delivering manufacturing campaigns in a highly regulated environment.

Requirements

  • Bachelor’s degree from an accredited college or university, STEM preferred and at minimum 3 years of direct experience
  • A BioWorks Certificate and/or associate's degree, STEM preferred and at minimum 5 years of direct experience
  • A High School Diploma (or equivalent) and at minimum 7 years of direct experience
  • Strong working knowledge of cGMP requirements with the ability to ensure compliant execution of manufacturing activities
  • Demonstrated experience being a lead, leading, supervising, coaching, and/or developing manufacturing teams
  • Experience leading training efforts across safety, GMP, and process-related activities, with a focus on compliance and performance

Nice To Haves

  • Experience troubleshooting downstream operational and equipment issues and coordinating maintenance, repairs, and changeovers
  • Experience drafting and revising manufacturing documentation, including batch records and SOPs

Responsibilities

  • Manage, coach, and develop Manufacturing Associates; identify skill gaps and implement development plans
  • Schedule and direct daily manufacturing operations, ensuring alignment with production timelines and priorities
  • Ensure all activities are executed in compliance with cGMP standards and that team members are fully trained prior to execution
  • Partner cross-functionally with QC, QA, Materials Management, MS&T, Validation, Facilities, and Engineering to support batch execution, sampling, and validation activities
  • Lead and support training efforts across safety, GMP, and process-related activities; monitor and improve safety performance
  • Troubleshoot operational and equipment issues; coordinate maintenance, repairs, and changeovers with Facilities
  • Draft and revise manufacturing documentation, including batch records and SOPs

Benefits

  • Medical, Dental, Vision, & Life insurances
  • Fitness & Wellness programs including a fitness reimbursement
  • Short- and Long-Term Disability insurance
  • A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
  • Up to 12 company paid holidays + 3 paid days off for Personal Significance
  • 80 hours of sick time per calendar year
  • Paid Maternity and Parental Leave benefit
  • 401(k) program participation with company matched contributions
  • Employee stock purchase plan
  • Tuition reimbursement of up to $10,000 per calendar year
  • Employee Resource Groups participation
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