Job Description

About RevoGen Biologics LLC

RevoGen Biologics is committed to making lives better through cutting-edge biologics. Following time-tested rigorous guidelines, delivering quality products and services to our clients is our number one goal. We created RevoGen® Biologics with a client-centric mission in mind. Built on a solid foundation of best-practices and trust-driven relationships, we aim to improve the lives of everyone who uses our products. From doctors and surgeons to patients and distributors, we strive to deliver the most optimal experience for every person who interacts with RevoGen Biologics. Following rigorous, time-tested guidelines and conducting stringent donor screenings, we’re revolutionizing the field of bioregeneration to offer physicians and their patients quality biologics. 

Job Title: Tissue Bank Director

Location: San Antonio, Texas, USA

Department: Medical Affairs

Reports To: Medical Director

FLSA Status: Exempt

Position Summary

The Tissue Bank Director serves as the clinical expert for donor suitability, tissue recovery, processing criteria, supply requirements, quality metrics, and tissue training for the organization. The Tissue Bank Director provides leadership and oversight for all ocular, wound care, and bone filler tissue banking operations, including the recovery, processing, preservation, storage, and distribution of human ocular tissues and skin/amniotic or bone filler grafts used in transplantation, ophthalmic surgery, and advanced wound care. The Tissue Bank Director is responsible for creating an annual budget, forecasting tissue projections and revenue, and maintaining fiscal accountability within the department. In addition, the Tissue Bank Director is responsible for negotiating, executing, and adhering to processor and supplier agreements, including defined monthly, quarterly, and annual tissue allocation caps. The Tissue Bank Director is accountable for the tissue recovery staff’s adherence to all regulatory and accrediting agency standards, including, but not limited to CMS, FDA, and AATB, as well as all internal organizational policies, procedures, and guidelines. The Tissue Bank Director is responsible for strategic planning as it relates to departmental, tissue program, and donor network growth, and investigating business opportunities that lead to an increase in tissue donation and/or improvement in clinical outcomes.

 The Director ensures compliance with applicable regulations, including FDA 21 CFR Part 1271, AATB Standards, EBAA Standards, and state tissue banking requirements.

This role oversees supplier relationships, donor screening, validation, labeling, and release to maintain the highest standards of safety, sterility assurance, and ethical integrity.

Essential Duties and 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.

Required Qualifications

· Bachelor’s degree in Life Sciences, Biomedical Engineering, or related field required.

· Advanced degree (MS, MPH, MBA, or PhD) preferred; CTBS certification strongly encouraged.

· Certified Tissue Bank Specialist (CTBS) certification preferred.

· 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.

Competencies

· 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.

Work Environment & Physical Requirements

• This role operates within a combination of office, laboratory, and controlled cleanroom environments.
• Regular use of computers, phones, and office equipment.
• May require occasional lifting of materials up to 25 pounds.
• Exposure to manufacturing floor environments.
• May require standing for extended periods and occasional travel for audits or site visits.
• Compliance with biosafety and infection control protocols required.

Travel Requirements

• Occasional domestic travel may be required (approximately 10–20%) to support supplier evaluations and supplier business meetings.

Compensation & Benefits

• Competitive base salary commensurate with experience.
• 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.

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