Sample Management Head

Job Title
:
Sample Management Head

• Location: Swiftwater, PA

Sanofi is recruiting for a Sample Management Head to support a diverse and growing portfolio of vaccines targeting infectious diseases. The Sample Management Head is accountable to oversee and drive all operational aspects of the human biological sample (HBS) management and Biorepository Center of Excellence (BCOE) activities at multiple geographical Global Immunology sites, including Swiftwater, Waltham, Orlando and Marcy l’Etoile. This position will be responsible for managing clinical and non-clinical HBS required for the continued, uninterrupted clinical testing, for the development/validation and performance monitoring of the bioanalytical assays performed at Global Immunology sites and Contract Research Organizations (CROs) and to ensure that HBS are available to meet the project goals on time and with the appropriate GxP expectations and quality.

Will be primarily accountable to identify and ensure that operational “best practices” policies & procedures for HBS management are developed, implemented at all respective sites and harmonized globally in line with company and regulatory requirements.

Additionally, as the BCOE lead for vaccines, this role will coordinate local BCOE inventories in a performant and cost-efficient way, in compliance with global BCOE governance and local regulations and in close collaboration with local functions and external storage provider. This is achieved through coordination with GI Sample Management to obtain information on backlog of physical inventory in freezers and cold rooms, extraction of metadata from agreements or databases (i.e. LIMS) and communication with Azenta for offsite storage and data wrangling on the input of samples to the BSM program.

The successful applicant will demonstrate applicable competencies and behaviors including strategic thinking, commitment to partners, and transversal cooperation across multiple global functions both internally to Sanofi and externally.

Join the engine of Sanofi’s mission — where deep immunoscience meets bold, AI-powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions.

We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.

• Lead a large team with multiple direct and indirect reports to oversee sample management and chain of custody with internal and external laboratories to support the entire Sanofi portfolio and coordinate Sanofi strategy.
• Manage the day-to-day logistical operations of Sample Management personnel within Strategic Alliances and ensure best practices are applied uniformly across all sites.
• Provide operational oversight of clinical and non-clinical HBS management (e.g. accessioning, aliquoting, distribution, archiving, and destruction) to ensure sample quality and integrity and full traceability from receipt through destruction using LIMS systems.
• Represent the team on project, process, and investigation teams, ensuring appropriate planning, organization, and resource allocation.
• Ensures laboratory resources (materials/equipment/facilities) are maintained to meet assigned objectives; evaluates performance/metrics of laboratory/project in relation to objectives and effectively communicates to the management.
• Interact and liaise within the other platform leads, SME and GI department heads across all sites to ensure end-to-end GI communication is maintained and issues are escalated to GI leadership.
• Accountable for in scope clinical study deliveries to agreed time and quality, and for reporting of relevant metrics to Late Stage Immunology Leadership team.
• Investigate deviations from established procedures to ensure effective corrective actions are implemented as well as identify gaps in the sample management process to maximize efficiency…