Sample Management Head

Sanofi • Swiftwater, PA

6d

About The Position

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.

Requirements

• BS degree in life sciences, or MS in immunology, microbiology, virology or biochemistry preferred.
• Minimum 8 years' of relevant experience, or Masters' in Life Science with 5 years' of relevant experience, preferably in pharma R&D.
• Experience with GXP practices and procedures required.
• Understanding of clinical supply and testing logistics.
• Experience in maintaining laboratories, documentation and equipment in GXP compliance.
• Understanding of inventory management and logistics.
• Experience with working in compliance with current regulations (FDA, EMA, ICH).
• Proficient verbal and written communication, organizational and team management skills.
• Proven ability to implement new procedures/processes.
• Project management and computer skills required.

Nice To Haves

• Laboratory management and/or operations experience preferred with preference given to candidates who have performed project management of central laboratories.

Responsibilities

• 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 gains and deliver samples from the clinical sites to the testing labs faster and with reduced errors.
• Accountable for compliance of the clinical sampling lifecycle via planning, risk management and monitors progress to track study delivery to resources, time and quality.
• Collaborate with pharma BCOE heads on overall BCOE objectives and serve as the coordinator for vaccines across SWT, WAL, ORL & MLE.
• Provide support during regulatory inspections and audits and ensuring compliance with pharmaceutical regulations, guidelines and standards.
• Coordinate off-site storage with Azenta, data wrangling as needed, support BioSource deployment with scientists, be the key user for BioSource onsite.
• Perform first level compliance check to ensure correct use based on sample type and local and global rules and regulations e.g., commercial licenses and ethical use, coordinate more specific questions with Global BCOE Compliance expert.
• Install processes and guide scientists as BCOE expert to support acquisition of biosamples including sample receipt and registration, support transfer requests of biosamples internally and to external partners and coordinate shipment of requested biomaterials with logistics department ensuring compliance.
• Be a part of a Global organization and interact with groups across multiple time zones.

Benefits

• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level