GCI Ligand Binding Assays Team Lead- Vaccines

Role Summary

GCI Ligand Binding Assays Team Lead – Vaccines. Location: Swiftwater, PA. 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.

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.
• 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 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.

Skills

• 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.

Education

• 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 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.
• Proven leadership, verbal and written communication, organizational and team management skills.
• Proven ability to develop and implement new procedures/processes.