Shane Bokhary
Biopharma operations industry leader with 20 years of experience in GMP manufacturing
Founder & CEO of @BioEdgecounsultingLLC · Houston, TX, USA
Open to advisory
Customer acquisition · Engineering & Tech · Operations & Finance · Leadership & Strategy
Makes warm intros to
5
Hours / month
About Shane
Shane Bokhary is Founder & CEO of BioEdge Consulting LLC, a strategic operations partner to biopharma companies advancing cell therapy, viral vector, and GMP manufacturing programs. With 20+ years leading biopharmaceutical operations, Shane specializes in building high-performing, compliant manufacturing organizations, accelerating tech transfers, and delivering rapid, cost-conscious scale-up from early development through commercial readiness. He has directed multi-site MSAT, manufacturing science, and operations teams to achieve FDA approvals, successful PAI readiness, and multi-million-dollar business wins. Previously recognized for exceptional process improvements and training efficiency, Shane excels at aligning cross-functional teams with regulatory requirements and corporate goals to drive operational excellence in ATMPs and related modalities. Currently guiding clients through BLA/IND timelines, risk assessments, and robust GMP systems, he partners to turn ambitious science into scalable, quality-driven manufacturing outcomes.
Company
BioEdge Consulting
bioedgeconsultingllc.com
BioEdge Consulting delivers strategic, operational, and regulatory expertise to support the development and commercialization of advanced therapies. We partner with drug developers, CDMOs, and life sciences organizations to navigate complexity, mitigate risk, and drive execution across manufacturing, quality, and capital programs. Our approach is hands-on, practical, and grounded in real-world GMP experience—helping transform innovation into compliant, scalable, and sustainable solutions that ultimately improve patient outcomes. Our mission is to partner with life sciences organizations to deliver compliant, scalable solutions that turn innovation into impact.
Company Stage
Launch
Funding Stage
Unsure
Funding Raised
None/Bootstrapped
Team Size
1-5 employees
Annual Revenue
$100k to $250k
Founded
2025
Industry
Services
Skills
GMP Manufacturing
Shane has deep expertise in GMP manufacturing programs, rigorous compliance, and implementing robust GMP systems.
Biopharmaceutical Industry
Shane has 20+ years of leadership experience specifically within the biopharmaceutical sector.
PAI Readiness
Shane has led successful PAI readiness initiatives, ensuring regulatory compliance for manufacturing facilities.
FDA Approval
Shane has directed teams to achieve multiple FDA approvals for biopharmaceutical products.
Entrepreneurship
As Founder & CEO of BioEdge Consulting LLC, Shane built and leads a strategic operations consulting firm for biopharma.
Founded company
Shane successfully founded and leads BioEdge Consulting LLC.
Leadership
Shane has 20+ years of experience leading biopharmaceutical operations and directing multi-site teams.
Operations Management
Shane specializes in building high-performing, compliant manufacturing organizations and optimizing site operations.
Regulatory Affairs
Shane has extensive experience with FDA approvals, PAI readiness, BLA/IND timelines, and regulatory documentation.
Quality Management
Shane focuses on turning science into scalable, quality-driven manufacturing outcomes and optimizing quality systems.
Business Growth
Shane has secured multi-million-dollar business wins and contributes to sustainable operational excellence.
Viral Vector Manufacturing
Shane has expertise in strategic operations for biopharma companies advancing viral vector programs.
Cell Therapy
Shane specializes in strategic operations for biopharma companies advancing cell therapy programs.
Manufacturing Scale-up
Shane excels at delivering rapid, cost-conscious scale-up from early development through commercial readiness.
Strategic Planning
Shane acts as a strategic operations partner, aligning cross-functional teams with corporate goals and defining strategies for scale.
Advanced Therapy Medicinal Products (ATMPs)
Shane drives operational excellence specifically in ATMPs and related modalities.
Technology Transfer
Shane specializes in accelerating technology transfers for biopharma manufacturing processes.
Process Improvement
Shane is recognized for implementing exceptional process improvements and driving operational excellence.
Business Development
Shane's firm secures strategic partnerships to deliver scalable and quality-driven manufacturing outcomes.
Organizational Development
Shane specializes in building high-performing, compliant manufacturing organizations from the ground up.
Cross-functional Team Leadership
Shane excels at aligning cross-functional teams with regulatory requirements and corporate goals.
Risk Assessment
Shane guides clients through risk assessments, including FMEA and comparability studies, to minimize risk.
Consulting
Shane is Founder & CEO of a consulting firm providing strategic operations partnership to biopharma clients.
Client Management
Shane partners directly with biotech and pharmaceutical teams, providing tailored senior guidance.
Process Development
Shane brings hands-on expertise in process development to optimize manufacturing operations.
Deviation Management
Shane brings hands-on expertise in deviation management to ensure compliant manufacturing processes.
Facility Start-up
Shane has hands-on expertise in facility start-ups within the biopharmaceutical sector.
Training & Development
Shane has a proven track record in enhancing training efficiency within biopharmaceutical operations.
Cost Management
Shane employs cost-conscious scale-up and cost-aware governance to optimize operational expenditures.
Project Management
Shane manages complex programs, guiding clients through BLA/IND timelines and project execution.
Experience
job
Founder & CEO
BioEdge Consulting LLC
Leads a strategic operations consulting firm for biopharma companies, focusing on advancing cell therapy, viral vector, and GMP manufacturing programs. Responsible for guiding clients through BLA/IND timelines, risk assessments, and robust GMP systems, while optimizing site operations, accelerating tech transfers, and ensuring GMP compliance.
Founded BioEdge Consulting LLC, successfully establishing a firm that partners with biotech and pharmaceutical teams to transform complex operations into reliable, scalable, and compliant manufacturing engines, shortening time-to-market.
job
Biopharmaceutical Operations Leader
Biopharmaceutical Industry
Over 20 years, led biopharmaceutical operations, specializing in building high-performing, compliant manufacturing organizations and accelerating tech transfers. Directed multi-site MSAT, manufacturing science, and operations teams, delivering rapid, cost-conscious scale-up from early development through commercial readiness.
Successfully led the start-up and scale-up of six GMP facilities, including a licensed commercial facility where I supported pre-approval inspection (PAI) readiness and achieved FDA approval. Recognized for exceptional process improvements and training efficiency across ATMPs and related modalities.