Sanofi Group Senior Scientist in Framingham, Massachusetts

Sanofi-Genzyme is seeking a Senior Scientist with an established background in process analytics for a position based at their Framingham, MA site. The qualified candidate will join the Bioprocess Analytical group and will provide in-process support sample testing and high throughput assay automated assay development. The individual in this role will have hands-on experience with automated liquid handling robotic systems and other automated workstations. The successful candidate will be expected to extend our existing expertise in high throughput and automated analytics and to actively apply new concepts as appropriate to continuously improve functional area capabilities.

The ideal candidate is required to have significant experience with biological analysis and characterization of biologic therapeutic protein products using ELISA-based immunoassays, label-free binding assays, and antibody-based affinity assays. The candidate will take a leading role in the development, and qualification of immunoassays for biological activities, product and process-related protein impurities to support the process development group. The successful candidate will be expected to make detailed observations, analyze data, interpret results, and exercise appropriate technical judgment in the design, execution, and interpretation of experiments in an independent manner.

Responsibilities

  • Support upstream and downstream process development with analytical sample testing; thoroughly analyze and compile results, solve analytical problems and assay troubleshooting

  • Develop new high throughput and/or automated analytical methods/workflows for process intermediate monitoring; improve existing methods and transfer current low throughput assays onto high throughput automated liquid handling and microfluidic platforms.

  • Apply new cutting-edge technologies to improve throughput in-process testing and enhance capability of product biological characterization..

  • Prepare technical reports, Standard Operating Procedures (SOP) qualification reports, study protocols; contribute to scientific journal publications and presentations.

  • Mentor, train/lab supervision of junior Research Associates in analytical methods transfer, implementation, execution and documentation

Basic Qualifications

  • Ph.D. in Analytical Chemistry, Chemical Engineering, Biochemistry, Biological Sciences, Biology or equivalent with more than 5+ years of industrial experience working in a biotechnology/pharmaceutical company or M.S. with10+ Experience in designing and implementing automated laboratory workflows and high throughput analytical methods is required.

  • Experience in the automation of ELISA assays and other plate-based assays, binding assays, qPCR etc. using various automation platforms (TECAN, BioMek, Bravo, Hamilton); programming knowledge in script writing..

  • Programming knowledge for the creation of new automated methods and to aid in troubleshooting scripts is preferred.

  • Experience in the measurement of process impurities (HCP assay using ELISA and Gyros; residual DNA by qPCR and Residual Pro A by UPLC and other methods)

  • Expert in forté Bio Octet quantitation methods development, qualification and implementation for assay support

  • Experience with antibody-affinity chromatography techniques, including ligand immobilization

  • Knowledge in other chromatographic and electrophoresis (cIEF, CE-SDS) separations is a plus

  • Proficiency in assay validation/qualification and transfer.

  • Knowledge in regulatory guidelines, including GMP and GLP is desirable.

Preferred Qualifications

  • Experience in analytical methods development and qualification following ICH guidelines.

  • Experience working with multidisciplinary teams in a matrix environment

  • Well-organized, strong scientific curiosity, self-motivated, hard-working and detail-oriented individual able to work successfully in both a team/matrix environment as well as independently.

  • Excellent written and verbal communication skills.

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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