Associate Director, Human Biorepository Operations
2 weeks ago
Farmington, CT
This position holds the responsibility of ensuring streamlined and efficient operational functions across diverse areas within the organization. This role involves overseeing space utilization, support processes, and the operational area environments in support of the JAX mission. Upholding stringent operational policies and protocols while achieving quality and efficiency goals constitutes the core focus of this role. The incumbent will spearhead the implementation of policies and systems to optimize overall operational functionality and ensure client satisfaction.
Key Responsibilities (What you contribute)
- Provide strategic and operational leadership for Biorepository program development and management of human biospecimens and cellular models across JAX's translational research programs.
- This role is responsible for developing and implementing policies, SOPs, and quality systems that ensure integrity, traceability, documented provenance and regulatory compliance in biorepository operations and distribution of human cellular models to the research community.
- This role will collaborate with internal and external stakeholders to ensure that best practices are implemented to support high-impact research and clinical initiatives.
- Lead the development and execution of biorepository strategy aligned with institutional research goals and cellular models for distribution.
- Serve as the primary point of contact for biorepository operations across clinical and translational research programs.
- Establish and maintain comprehensive policies and SOPs for biospecimen collection, processing, storage, and distribution.
- Ensure alignment with regulatory, ethical, and institutional standards.
- Leads initiatives for the sourcing of human samples, ensuring robust donor consent, adherence to regulatory and ethical standards (e.g., IRB, GDPR, HIPAA), and the maintenance of documentation for compliance audits.
- Ensure alignment with regulatory, ethical, and institutional policy and standards.
- Oversee the full lifecycle of human biospecimens, including acquisition, inventory, storage, retrieval, and disposal.
- Implement and manage biospecimen tracking systems to ensure data integrity and sample traceability.
- Develop standard clinical metadata templates for data linked to biospecimens
- Implement and manage data tracking systems to ensure data integrity and sample traceability.
- Develop and monitor sample acquisition protocols, ensure appropriate IRB approvals are obtained and maintained.
- Develop and monitor quality control metrics and corrective action plans resulting from audits.
- Ensure compliance with applicable regulations (e.g., HIPAA, IRB, CAP/CLIA) and support audit readiness.
- Partner with clinical sites, research teams, and data management to ensure biospecimen needs are met.
- Provide training and mentorship to biorepository staff on best practices and quality standards.
- Evaluate and implement biorepository management systems and automation tools.
- Stay informed of emerging trends and technologies in biobanking and biospecimen science.
- Demonstrated experience in SOP development, sample management systems, and quality assurance.
- Master's degree in life sciences, clinical research, or related field; Ph.D. preferred;
- Minimum 5 years of experience in biorepository or biospecimen operations, with at least 3 years in a leadership role
- Minimum 3 years of experience in compliant management and provision of human genomic and other omics data to NIH standards.
- Strategic Thinking: Ability to align biorepository operations with institutional research priorities and long-term goals.
- Operational Excellence: Proven ability to manage complex workflows and optimize systems for efficiency and quality.
- Regulatory Acumen: Deep understanding of biospecimen-related regulatory and ethical requirements.
- Leadership & Influence: Strong leadership presence with the ability to guide cross-functional teams and influence stakeholders.
- Attention to Detail: High standards for data accuracy, sample integrity, and documentation.
- Communication: Excellent written and verbal communication skills, including SOP authorship and stakeholder engagement.
- Problem Solving: Proactive and analytical approach to identifying and resolving operational challenges.
- Familiarity with regulatory frameworks such as HIPAA, IRB, and CAP/CLIA
- Experience with Laboratory Information Management Systems (LIMS) or biorepository software platforms
- Knowledge of New York State Repository (tissue banking) regulations, preferred.
Pay Range: $106,020 - $153,729
About JAX:
The Jackson Laboratory is an independent, nonprofit biomedical research institution with a National Cancer Institute-designated Cancer Center and nearly 3,000 employees in locations across the United States (Maine, Connecticut, California), Japan and China. Its mission is to discover precise genomic solutions for disease and empower the global biomedical community in the shared quest to improve human health.
Founded in 1929, JAX applies over nine decades of expertise in genetics to increase understanding of human disease, advancing treatments and cures for cancer, neurological and immune disorders, diabetes, aging and heart disease. It models and interprets genomic complexity, integrates basic research with clinical application, educates current and future scientists, and provides critical data, tools and services to the global biomedical community. For more information, please visit www.jax.org.
EEO Statement:
The Jackson Laboratory provides equal employment opportunities to all employees and applicants for employment in all job classifications without regard to race, color, religion, age, mental disability, physical disability, medical condition, gender, sexual orientation, genetic information, ancestry, marital status, national origin, veteran status, and other classifications protected by applicable state and local non-discrimination laws.
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