GCI Ligand Binding Assays Team Lead- Vaccines

Job Title: GCI Ligand Binding Assays Team Lead- Vaccines

Location: Swiftwater, PA

About the Job

The Head of the Ligand Binding Assay (LBA) platform directs multiple laboratories in developing, qualifying, validating, and executing LBAs to support vaccine clinical endpoints from Phase I to Phase IV. Responsibilities include strategizing new immunological ligand binding methodologies, optimizing existing assays, and delivering high quality results in a GCLP regulated environment. Expertise in ELISA, Radio-Immuno Assay (RIA), Luminex, MSD, and Ortho VITROS platforms, is essential. 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

• Lead a large team of Bachelors, Masters, and Ph.D. scientists to develop, validate, and execute novel ligand binding bioanalytical methodologies for vaccine clinical endpoints.

• Optimize existing methodologies relevant to ELISA, Radio-Immuno Assay (RIA), Luminex, MSD, and Ortho VITROS related platforms delivering high-quality results in a GCLP-regulated environment.

• Collaborate closely with global project teams and immunology team leads.

• Drive continuous improvement and advancement of techniques and technologies for novel vaccine candidates at Sanofi Vaccines R&D.

• Represent the team on project, process, and investigation teams, ensuring appropriate planning, organization, and resource allocation.

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, 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.

• Act as a contributing author to high-quality publications describing assay development and/or the immunogenicity and efficacy of candidate and approved drugs in technical, medical, or scientific journals.

Essential Attributes

• Expertise in ELISA, Radio-Immuno Assay (RIA), Luminex, MSD, and Ortho VITROS platforms in a regulated environment.

• 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.

About You

Education and Background

• BS degree in life sciences with 15+ years of relevant experience, MS or Ph.D. in immunology, microbiology, virology, biochemistry or related life sciences degree (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