Revogen Biologics · 2 months ago
Tissue Bank Director
Boerne, TX
Full-time
Onsite
Director/ExecutiveRevoGen Biologics is committed to making lives better through cutting-edge biologics. The Tissue Bank Director serves as the clinical expert for donor suitability and oversees all tissue banking operations, ensuring compliance with regulatory standards and managing staff training and operational budgets.
BiotechnologyMedical DeviceWholesale
Responsibilities
Provide strategic leadership for ocular and wound graft tissue bank operations, including donor recovery, processing, packaging, labeling, and distribution
Ensure full compliance with FDA 21 CFR 1271, AATB, and EBAA accreditation standards
Develop, implement, and maintain Quality Management Systems (QMS) consistent with cGMP, cGTP, and ISO 13485
Oversee donor eligibility determinations, donor records, and traceability of grafts
Ensure sterile technique, aseptic processing, and validated preservation procedures for ocular and wound grafts (e.g., amniotic membrane, dermal tissue)
Manage staff training, competency assessments, and annual evaluations in compliance with AATB/EBAA standards
Coordinate audits, inspections, and accreditation site visits; ensure timely response and corrective actions
Review and approve all SOPs, validation studies, and change controls related to tissue processing and distribution
Monitor product release, labeling, and final distribution for compliance with regulatory and internal quality standards
Implement systems for product recall, deviation investigation, and complaint management
Ensure donor and recipient adverse event tracking and regulatory reporting as required
Foster collaboration with clinical partners, surgeons, and hospitals to ensure tissue quality and availability
Lead initiatives in process improvement, cryopreservation, and innovative wound care product development
Oversee documentation practices aligned with ALCOA+ data integrity principles
Promote a culture of compliance, safety, and continuous improvement throughout all tissue bank operations
Qualification
Required
Bachelor's degree in Life Sciences, Biomedical Engineering, or related field required
Demonstrated experience and favorable outcomes with FDA inspections, notified body audits, and supplier quality programs
Expertise in QMS software platforms and document control systems
Strong analytical, problem-solving, and decision-making skills
Strong understanding of ocular tissue recovery, amniotic membrane processing, and aseptic wound graft techniques
Proven ability to lead regulatory inspections and maintain accreditation
Excellent leadership, communication, and analytical skills
Proficiency in Quality Management Systems (QMS), document control, and risk management principles
Ability to interface effectively with surgeons, clinicians, and regulatory professionals
Preferred
Advanced degree (MS, MPH, MBA, or PhD) preferred; CTBS certification strongly encouraged
Certified Tissue Bank Specialist (CTBS) certification preferred
Benefits
Performance-based annual bonus eligibility.
Comprehensive benefits package, including medical, dental, vision and 401(k) with company match.
Paid time off, sick leave, and company holidays.
Professional development opportunities and continuing education support.
Company
Revogen Biologics
RevoGen Biologics is a biotechnology company that offers biologics and allograft tissues.
11-50 employees
Funding
Current Stage
Early StageLeadership Team
Jacob Chandler
CEO
Company data provided by crunchbase