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Job Title: Sample Management Coordinator

• Location: Swiftwater, PA

About the Job

This position will assist the Sample Management Head to oversee and drive all operational aspects of the human biological (HBS) management activities at the Swiftwater Late Stage Immunology. 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 Clinical Immunology and Contract Research Organizations (CROs) to ensure that sample are available to meet the project goals on time and with the appropriate GxP expectations and quality. Will help 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. 

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.

About Sanofi:
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.

Main Responsibilities:

• Accountable to oversee 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 via LIMS.

• Responsible for the inventory management of clinical and non-clinical HBS (e.g. PMP, assay controls, employee sera, commercially obtained sera, inter-lab sample panels).

• Ensure timely distribution of the relevant samples to testing labs, shipment to multiple SP R&D sites and CROs to support the continued clinical testing and meet project timelines.

• Identify improvements of current sample management processes ensuring compliance of procedures to regulatory requirements and assists with the creation and implementation of strategies, policies & procedures and assists with documentation management processes across multiple sites.

• Ensure 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.

• Training and supervision of Sample Management analysts and contractors on laboratory methods, procedures and techniques; oversee the day-to-day operations and general lab activities.

• Under direction of management, interact with key customers and external vendors and assists External Testing team in the execution of clinical testing at CROs by overseeing sample management activities and maintaining close and productive relationship.

• Assist the Sample Management Head to prepare relevant documentation, scientific presentations and reports, and budget planning, etc.

• Works with the responsible person for import/export permits and shipments to ensure relevant permits and other shipment documentation for HBS are up to date and available.

• Adheres to all applicable quality, corporate, safety, and regulatory requirements and ensures sample management laboratories are in an audit ready state at all times and assists with responses to audit findings as assigned to ensure that root cause is identified where possible and that corrective and preventive actions are identified, implemented, and effective.

Education:

• BS degree in life sciences, MS in immunology, microbiology, virology or biochemistry preferred.

Experience:

• At least 3 years of relevant experience in a laboratory setting, preferably in pharma R&D.

• Understanding of GXP practices and procedures required.

• Laboratory management and/or operations experience preferred.

• Familiarity with clinical or sample databases and inventory management required.

Technical skills:

• Familiarity with laboratory testing regulations both internally and externally (CROs).

• Entrepreneurial mindset with positive energy and strong sense of determination.

• Proficient verbal and written communication, organizational and team management skills.

• Proven ability to implement new procedures/processes.

Why Choose Us

• Bring the miracles of science to life alongside a supportive, future-focused team.

• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.

• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.

• 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.

• Be part of a pioneering biopharma company that engages patients early in drug development and uses their insights to design studies that reflect real-world needs.

• Help improve the lives of millions of people globally by making drug development quicker and more effective.

• Work at the forefront of drug discovery, harnessing cutting-edge AI, data, and digital platforms to push the boundaries of science.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.

Pursue Progress. Discovery Extraordinary.

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