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Job Title: Biosamples Lead - Vaccines

Location: Swiftwater, PA

About the Job

Sanofi is recruiting for a Biosamples Lead to support a diverse and growing portfolio of vaccines targeting infectious diseases. This role is accountable for strategic planning and oversight of all central laboratory and biobanking human biological sample related activities from initial study design, clinical testing and through to long term storage and study closure. The Biosamples Lead drives quality, consistency and compliance across their programs and they are the main driver of efficient operational deployment of internal and external clinical laboratory testing.  This is achieved through functioning as an intermediary between the Global Immunology (GI) Immunoleads, clinical operations, and the PPD central laboratories on operational activities to support kit building activities, processing instructions for biospecimens, review of central laboratory manuals, and creation of analytical testing plans.

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

We are an innovative global healthcare company that helps the world stay ahead of infectious diseases by delivering more than 500 million vaccine doses a year. Across different countries, our talented teams are exploring new technologies to protect people and promote healthy communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world.

Main Responsibilities:

• Support and coordinate logistical operations, including study startup activities, human biological sample label creation, sample management activities, testing, purchasing, and import of related reagents to support clinical testing.

• Accountable for in scope clinical study deliveries to agreed time and quality, and for reporting of relevant metrics to Late Stage Immunology Leadership team

• Maintains oversight of clinical sampling delivery within the assigned clinical programs, evaluates risks and escalates issues for resolution in a timely, accurate and compliant manner

• Leads a team of Biosamples managers to support the entire Sanofi portfolio and work with PPD Central lab lead to coordinate Sanofi strategy with PPD

• Lead the effort to communicate ongoing status of clinical sample collection and testing to all ongoing Sanofi clinical studies via updates to control room on a regular basis

• Oversight and coordination of activities related to off-site storage of completed clinical trial samples

• Oversee the authoring of key documents to support external clinical testing, including PPD Central Lab Specifications and Lab Manuals, Sanofi Operating Guidelines and Analytical Test Plans

• Provides and problem solves operational aspects of the inclusion of central laboratory testing of human biological samples into clinical programs and trials

• Accountable for compliance of the clinical sampling lifecycle via planning, risk management and monitors progress to track study delivery to resources, time and quality

• Coordinate with GI Immunoleads to author Sample Request Memos for investigation, development, qualification and validation of external test procedures.  This includes interfacing with PPD, clinical data managers and clinical biostatistics to bring together information of sample volume and consent with the key immuno readouts to select the proper samples.

• Be a part of a Global organization and interact with groups across multiple timezones

About You

• Earned Bachelor's in Life Science with 5 years' experience, OR Masters' in Life Science with 3 years' experience, preferably in pharma R&D

• Understanding of GXP practices and procedures required to work within a GXP lab

• Work experience in clinical trial conduct and/or biosample management

• Familiarity with clinical or sample databases and inventory management required

• Familiarity with laboratory testing regulations both internally and externally

• Experience with external vendors preferred (i.e. work with CROs)

• Laboratory management and/or operations experience preferred

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

• Proven ability to implement new procedures/processes within a team environment with little transition time

• Project management and familiarity with databases / computer skills

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.

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.

Werde Teil von Sanofi und starte mit uns in eine neue Ära der Wissenschaft – wo dein persönliches Wachstum genauso wegweisend ist wie unsere Arbeit. Wir investieren in dich, damit du weiterkommst, schneller denkst und Dinge möglich machst, die vorher undenkbar waren. Du wirst Grenzen verschieben, Gewohntes hinterfragen und smarte Lösungen entwickeln, die direkt bei den Menschen ankommen, für die wir da sind. Bereit, die Wunder der Wissenschaft zu jagen und Leben zu verbessern? Dann lass uns gemeinsam Großes bewegen – und das Außergewöhnliche entdecken.

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