We are seeking a visionary and execution-focused Senior Vice President of Operations to lead and scale our end-to-end operations as we transition from research-use-only (RUO) products into regulated markets.

This executive role sits at the intersection of production, regulatory affairs, quality systems, and supply chain, and is responsible for driving product development from concept through scale-up and commercialization. The ideal candidate is both a strategic leader and hands-on builder with deep expertise in biotechnology manufacturing, regulatory strategy, and global supply chain operations - ensuring delivery of high-quality products that enable advancements in cell-based research, diagnostics, and therapeutics worldwide.
Key Responsibilities
Operational & Executive Leadership

• Lead and scale end-to-end operations, including manufacturing, supply chain, and logistics
• Lead facility design, equipment qualification, process validation, and technology transfer
• Drive operational excellence via automation, lean manufacturing & continuous improvement
• Plan, budget, and manage operational capacity across custom and catalog product lines
• Expert user of Netsuite or a similar ERP system
• Partner with R&D, Commercial, and Finance to align product development

Regulatory Affairs & Compliance

• Develop and execute regulatory strategies to support product commercialization
• Support customer regulatory submissions by providing technical documentation and guidance
• Maintain strong relationships with regulatory agencies and industry partners
• Stay current with evolving regulatory requirements and industry best practices

Quality Management Systems

• Design and implement robust quality systems compliant with:
• USP standards
• ISO 13074, ISO 13485, ISO 9001
• cGMP and applicable regulatory requirements
• Oversee QA/QC functions and continuous improvement initiatives
• Ensure effective CAPA systems and audit readiness

Supply Chain & Logistics

• Develop and execute a robust, scalable end-to-end supply chain strategy aligned with company growth and regulatory requirements
• Establish and optimize demand planning, inventory management, and S&OP (Sales & Operations Planning) processes
• Lead supplier qualification, auditing, and performance management in compliance with ISO and cGMP standards including dual sourcing for critical materials
• Oversee logistics, distribution, and cold chain (if applicable), ensuring on-time delivery to customers and partners
• Build and manage relationships with key suppliers, CDMOs, and logistics providers

Qualifications
Education & Experience

• Advanced degree (PhD, MS, or equivalent) in Life Sciences, Engineering, or related field
• 15+ years of progressive leadership experience in biotechnology or medical device industries
• Proven track record in scaling operations, including manufacturing and supply chain functions
• Proven track record in regulatory strategies in product development and commercialization

Technical & Domain Expertise

• Deep expertise in biotechnology manufacturing, regulatory affairs, quality systems, and supply chain operations
• Experience with cell-based products, cell mimic materials, or related technologies
• Strong knowledge of ISO standards, USP, and cGMP requirements
• Experience supporting customer regulatory submissions and technical documentation
• Expertise in process development, tech transfer, supplier qualification, and supply chain scaling
• Expertise in Netsuite or similar ERP system

Leadership & Business Acumen

• Proven ability to lead complex, cross-functional organizations in fast-paced environments
• Strong strategic planning, budgeting, and P&L management experience
• Demonstrated ability to set and achieve operational and company-wide goals
• Entrepreneurial mindset with a hands-on, builder-oriented approach

Our salary ranges are calculated by role and level. Your position within that range will be determined by your job-related knowledge, skills, experience, relevant education, and training/certifications. In addition to those factors, we also examine internal equity as well as consider current market rate, and title may be assessed one level lower or higher accordingly. After you join the company your performance, contributions, and results along with business and organizational needs will affect your base salary. The base salary range for this full-time position is between $275,000 - $300,000 + benefits.