Shane Bigler
⭐ Senior Manufacturing Leader ⭐
- Role
- Director, Manufacturing at KBI Biopharma
- Location
- Raleigh, NC, US
- LinkedIn followers
- 500 followers
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
Director, Manufacturing
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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