• Job Description

  Req#: R2743557

  Sr. Principal/Distinguished Scientist Bioanalysis & Immunogenicity, DMPK

  The Bioanalysis and Immunogenicity team within the DMPK department at Sanofi is searching for a Senior. Principal Scientist/Associate Director for a critical role within our global organization. The successful candidate will be charged with leading a new team responsible for developing and running custom ligand-binding assays for research and development purposes. Assay applications will include pharmacokinetic (PK), immunogenicity (ADA) and biomarker (BM) assays in a non-regulated laboratory in Cambridge, MA, as well as overseeing transfer and execution of assays to regulated labs is also required.

  The applicant is expected to lead bioanalytical and immunogenicity work packages such as method development, qualification, validation and sample analysis. Expertise developing custom immunoassays on platforms as ELISA, ECL (MSD) and other state-of-the art systems is required. The successful candidate will possess excellent self-organization and documentation skills and will be expected to present and discuss their own scientific results and provide input to project teams. Significant onsite presence will be required to perform and oversee laboratory activities.

  We are looking for individuals who have relevant immunoassay development and qualification experience, preferably within the above-mentioned technology fields. Prior hands-on experience in a regulated bioanalytical laboratory (GxP) is a plus.

  Key Responsibilities Include:

  • Scientific responsibility for immunogenicity and bioanalytical analysis in both non-regulated and regulated settings

    • Devise bioanalytical strategy within a project

    • Design, develop and validate PK, BM and/or ADA assays

    • PK, BM and immunogenicity analysis to support in vivo

    • Transfer assays and monitor studies bioanalytical studies internally to other global R&D sites or externally to CRO partners

  • Work effectively with global project team members to support drug development projects

  • Generate, report, and discuss bioanalytical and biomarker results with integrative knowledge of how the data contributes to the drug development process

  • Author comprehensive bioanalytical plans and reports as well as relevant sections of clinical study reports, submission dossiers and publications

  • Actively contribute to scientific discussions and drive technical project progress

  • Manage a small team of scientists and technicians (3-5)

  Candidate Profile:

  • PhD with 7+ years relevant experience in a life sciences field that includes immunoassay development (e.g. biochemistry, immunology, biology, etc.); or MSc, with 9+ years of relevant experience. Level will be commensurate with experience.

  • Strong background in immunoassay development using technologies such as ELISA and MSD, Gyros, etc.

  • Strong knowledge of immunogenicity and principles of bioanalysis: familiarity of current bioanalytical and immunogenicity regulatory guidance (FDA/EMA/ICH) is a plus

  • Quality-oriented - Prior experience in a regulated bioanalytical laboratory (GLP/GCP/GCLP) is a plus.

  • Excellent time management and organization skills

  • Strong communication (verbal, written, interpersonal, listening) skills

  • Ability to work independently with minimal supervision

  • Ability to adapt to rapidly changing priorities

  • Ability to multi-task and meet timelines in a fast-paced environment

  • Ability and willingness to work in a laboratory

  • Team player

  • Excellent English skills (oral and written)

  • Knowledge of MS Office (Word and Excel)

  • Available for full time position with significant on-site presence.

  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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• About the company

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