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Biobank Lead (Senior Manager / Associate Director)
Flagship Pioneering, Inc. · Cambridge, United Kingdom · On-site · Posted yesterday
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About the job
About the role
Quotient is seeking an experienced, detail-oriented operational leader to run the management, process control, governance and quality leadership of its research tissue bank. Quotient's human tissue bank is the foundation of our proprietary high-resolution somatic genetics platform, which delivers insights into cellular and organ disease biology and discovers novel targets for the development of new medicines.
You will lead across the whole sample lifecycle, from procurement review and receipt through storage, use, reuse, transfer and disposal, and keep Quotient compliant with its Human Tissue Authority (HTA) research licence.
Reporting to the Head of Research Strategy and Operations, you will work closely with the Director of Partnerships to check that proposed research fits the permissions and restrictions attached to each collection. You will also be the central point of coordination between laboratory teams, Facilities, Procurement and Logistics, Project Leads and Data Infrastructure, so that colleagues get timely access to suitable samples with full end-to-end traceability.
This role combines ownership of the tissue bank with practical oversight of delivery. Success means reliable, well-organised inventory and chain-of-custody records, timely availability of samples for research, compliance with internal SOPs and HTA regulations, and effective resolution of any sample-related incidents.
Key responsibilities
• Biobank governance and strategy: Own Quotient's research tissue bank strategy, aligning governance, capacity, resources and operating systems with the research portfolio, and recommend investment and improvements. Report sample availability, integrity, traceability, compliance risks and incident trends to leadership.
• HTA compliance: Act as the HTA Designated Individual for Quotient's research licence, supervising licensed activities and making sure that staff, premises, storage and procedures meet HTA requirements. Develop SOPs, oversee training and competency assurance, and lead inspection readiness and responses, covering UK HTA, GDPR, research ethics and health and safety standards.
• Sample access and use authorisation: Review access, initial use, reuse and onward transfer against consent, research ethics approvals, licence scope and contractual permissions, and document each decision. Apply independent judgement to complex sample-use decisions, balancing scientific priorities with donor permissions, sample availability and governance requirements, and obtain specialist advice or further approvals where needed.
• Sample acquisition and custody: Own custody controls from handover at receipt through registration, storage, retrieval, distribution and disposal, including manifests, shipment conditions, acceptance checks, handovers and receipt acknowledgements. Set requirements for human tissue shipments and approve the release of inbound and outbound shipments, working with logistics colleagues who handle couriers and documentation. Provide cover for sample receipt and shipping, directly or through trained delegates.
• Inventory systems and traceability: Integrate sample inventory with LIMS and ELN records, keeping identifiers, parent–derivative relationships, quantities, locations, status and movement histories accurate through timely updates, controlled access and periodic reconciliation. Ensure accurate annotation and metadata for all biospecimens, work with the Data Infrastructure team to bring sample data into research pipelines, and report on utilisation, inventory status and operational metrics.
• Storage integrity and continuity: Manage storage organisation and capacity with laboratory and facilities colleagues. Work with the team that owns the temperature-monitoring system to make sure it is fit for purpose and supports HTA compliance, sign off monitoring procedures and the training of staff who use it, and check calibration and alarm-test records as part of routine internal audits. Own specimen decisions during alarms and recovery, including integrity assessment, transfers, holds and incident recording, and agree documented default actions so that out-of-hours response does not wait for a specimen decision.
• Incident resolution and corrective action: Escalate concerns, pause non-compliant activities and hold samples where eligibility, documentation or integrity is unresolved. Run a quality-driven incident process, track corrective and preventive actions and approve closure.
• Capability and culture: Build capability through coaching, knowledge sharing and effective cover arrangements across the biobank and sample-management network. Create an environment where colleagues raise concerns, learn from incidents and share accountability.
About you
You are an experienced biobanking or human tissue governance leader who combines sound regulatory judgement with practical delivery. You can make and explain proportionate decisions, influence across functions and build quality-based systems that support a growing research portfolio.
Essential criteria
• BSc in Biological Sciences, Biomedical Sciences or a related discipline, or equivalent relevant experience.
• More than 5 years working with human biological samples in a research, biotechnology, biobank or clinical laboratory setting, including leadership of sample governance and operations across the sample lifecycle.
• Demonstrated leadership, including setting direction, developing colleagues and capability, influencing senior stakeholders without direct authority, and resolving competing priorities.
• Experience working across a variety of quality systems, and able to interpret guidelines and apply basic principles in a research setting.
• Experience reviewing consent, ethics and provenance documentation, interpreting sample-use restrictions, and assessing proposed use, reuse and transfer in collaboration with scientific, partnerships and legal colleagues.
• Experience reviewing sample-related provisions in MTAs, SLAs, MSAs or equivalent agreements and translating those obligations into operational controls.
• Proven ownership of sample accessioning, chain of custody, storage, database inventory and distribution processes, with practical experience of LIMS, ELN or comparable systems and their data quality and access controls.
• Strong working knowledge of the Human Tissue Act 2004, HTA research licensing and relevant standards, with experience supporting or leading licensed activities.
• Experience developing controlled documentation, training staff, preparing for audits or inspections, and leading incident investigations, corrective and preventive actions and documented closure.
• Excellent organisational skills, attention to detail and professional judgement, with a commitment to donor respect, confidentiality, scientific quality and continuous improvement.
Desirable criteria
• Previous appointment as an HTA Designated Individual, or substantial experience as a Person Designated with responsibility for tissue governance, inspections and compliance improvement.
• Familiarity with handling low-complexity clinical data and associated regulatory frameworks (GDPR).
• Experience in genomics, molecular biology or high-throughput research, including support for histology, flow cytometry or molecular workflows.
• Experience with cryogenic storage, freezer monitoring, sample integrity assessment and business continuity arrangements.
• Knowledge or experience of REC applications.
• Experience coordinating domestic and international sample transfers, external biobanks, offsite sample storage companies or CROs, and working with third-party logistics teams within a growing biotechnology organisation.
• Experience developing colleagues or leading a biobank or sample reception team, and implementing inventory platforms or significant process improvements.
• Evidence of building or improving tissue bank processes and systems, planning capacity and r
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