Location: Swiftwater,PA, USA
Job Title: GCI Scientific Logistics and Assay Lifecycle Management Team Lead - Vaccine
Location: Swiftwater, PA
About the job
The Scientific Logistics and Assay Life Cycle Management Team Lead is responsible for optimizing operational, scientific, and safety aspects across GCI, while efficiently allocating staff resources to meet business priorities. This role involves collaborating with GCI platform heads and Global Immunology leads to identify operational needs, address bottlenecks, and implement best practices. Key responsibilities include resource management, developing and implementing tools for monitoring assay performance, and driving continuous improvement. The successful candidate will ensure operational efficiency and foster a culture of continuous improvement within GCI. This position reports to the Head of Global Clinical Immunology and is based in Swiftwater, PA
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
Primary responsibilities
* Collaborate with platform heads to optimize the assay lifecycle, streamline processes, and maintain quality control through performance monitoring.
* Strategically prioritize digital and equipment needs across GCI
* Ensure timely and compliant closure of clinical assay investigations.
* Lead a team of transversal SLA's
* Provide oversight to GCI Health, Safety, and Environment (HSE) functions.
* Translate scientific requirements into operational strategies supporting organizational goals.
* Main point of contact for GCI digital and FELS needs
* Monitor equipment readiness and functionality.
* Strategically allocate resources across projects to meet demand effectively.
* Lead documentation efforts to ensure compliance and process efficiency.
* Identify and implement process improvements and best practices.
* Monitor key performance indicators (KPIs) for operational performanceBottom of Form
Management of Key Interfaces:
* Interact and liaise within the other platform leads and GI department heads and scientists to ensure end-to-end GI communication is maintained.
* Serve as function representative and SME at key strategic internal/external meetings, conferences/congresses, and key meetings with CROs and with regulatory authorities.
* Act transversally (including with global transversal operations, clinical development, Digital, FELS, global regulatory affairs) to build and optimize novel bioanalytical methods for fast-moving projects to maximize scientific quality and timeliness whilst operating within budget targets.
About You
Essential Attributes
* Proven experience in operations management within the biotech or pharmaceutical industry.
* Experience managing teams of 10+ individuals.
* Experience with quality systems and processes in a regulated environment
* Expertise with LIMS systems, reagent characterization and qualification, laboratory equipment and supplies.
* Ability to interact effectively with people from diverse cultural backgrounds and skill sets to achieve scientific and operational excellence.
* Strong commitment to scientific excellence and innovation.
* Excellent interpersonal skills to ensure target completion and foster workplace respect.
* Leadership that promotes cross-group collaboration to achieve Sanofi R&D goals, and developing leadership skills in direct reports.
* Record of innovation as evidenced by a strong publication record, inventorship on patents/filings and presentations at major conferences.
* Proven experience in management of personnel, budget, and projects.
Education and Background
* BS degree in life sciences with 15+ years of relevant experience, MS or Ph.D. in immunology, microbiology, virology or biochemistry (MS requires 12 + years, Ph.D 8+ years of relevant experience).
* 5+ years experience working in a regulated laboratory as a research scientist or laboratory manager preferably in pharma R&D.
* Experience in the development of new bioanalytical characterization methods for vaccines.
* Familiar with a broad range of functional bioanalytical and LBA instrumentation and techniques.
* Strong familiarity with immunogenicity assays.
* Understanding of GXP practices and procedures required.
* Work experience both in early phase product development and clinical stage.
* Laboratory management and/or operations experience preferred.
* Familiarity with clinical or sample databases and inventory management required.
* Proven leadership and managerial experience in multi-functional and matrixed teams.
* Familiarity with laboratory testing regulations
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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Pursue progress, discover extraordinary
Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!
US and Puerto Rico Residents Only
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; 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.