Shane Bigler

⭐ Senior Manufacturing Leader ⭐

Role
Director, Manufacturing at KBI Biopharma
Location
Raleigh, NC, US
LinkedIn followers
500 followers
Manufacturing & ProductionView LinkedIn profile

About Shane Bigler

I am a patient-focused, engaging, and experienced Senior Manufacturing Leader and Relationship Development professional with the unique ability to successfully lead multidisciplinary teams. I can ensure a high level of quality and safety, seamlessly develop and expedite the drug delivery process, maximize output and efficiency, improve patients\' lives and, build and grow high performing teams. Some of my core competencies include: Continuous Improvement Capital Projects Validation & Commissioning ComplianceScale-up Process Implementation Tech Transfer Process Transfer Large & Small Scale Purification & Cell Culture Biologics & Oligonucleotide Manufacturing Coordination & training Prior to joining Biogen, I served as a US Naval nuclear reactor operator for 6 years, where I specialized in secondary (steam) plant operations as a Nuclear Machinist Mate 1st Class. I gained valuable experience in leadership, supervision, quality assurance, radiological controls, fire fighting, first aid, and surface warfare. I graduated from the Naval Nuclear Power School, a rigorous and prestigious program that trains naval personnel in the theory and operation of nuclear reactors.

Experience

  1. Director, Manufacturing

    KBI Biopharma

    Sep 2024 — Present · Durham County, NC, US

    Cell Culture, Purification, Support, and Scheduling

Education

  • Thomas Edison State University

    Bachelors degree, Nuclear Engineering Technology

    2005 — 2008

  • Association for Supply Chain Management

    Certified Supply Chain Professional, Supply Chain Management

  • Farmingdale State College

    Aeronautical Science

    1994 — 1995

  • Nuclear Power School - Naval Nuclear Power Training Command (NNPTC)

    Nuclear Power

    1997 — 1998

Skills

  • Six Sigma
  • Concurrent Manufacturing
  • Process Development
  • Biotechnology
  • Leadership Development
  • Navy
  • V&V
  • Process Simulation
  • Large Scale Systems
  • Compliance
  • Technical Transfers
  • Team Leadership
  • Small Scale Systems
  • Process Validation
  • Quality Assurance
  • Nuclear
  • Scale-Up
  • Process Manufacturing
  • Manufacturing
  • Engineering
  • Process Implementation
  • Maintenance
  • Coaching

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Shane Bigler — Director, Manufacturing at KBI Biopharma in Raleigh, NC, US | Unifers