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ResponsibilitiesJob ID 4419384 Date posted 04/10/2017
Job Responsibilities/Department Description:
The person must be a technical and scientific expert in the field of in-process analytical sciences for biologics and related product. The ideal candidate will join the BioProcess Analytics group and will work closely with upstream and downstream BioProcess Development organization and continuous manufacturing departments for the implementation of advanced monitoring devices, multi-attribute measurement sensors, and PAT technologies. The individual is also responsible for analytical testing support, including sample preparation and analysis for Sanofiâ€™s biologics product. It is required to effectively use the current available technologies and develop cutting edge process analytical technologies (PAT) methods for at-line, online and inline monitoring of product attributes for in-process monitoring and control.
- 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 (at-line, online and in-line) methods/workflows for process monitoring; improve existing methods and transfer current low throughput assays onto high throughput platforms.
- Develop novel in-line, on-line, and at-line process analytical technology (PAT) methods for real time and near real time monitoring of key product quality attributes and process impurities.
- Contribute to documentation and preparation of reports and scientific presentations.
- Prepare technical reports, Standard Operating Procedures (SOP) qualification reports, study protocols and reports, and scientific journal publications and presentations.
- Mentor, train/lab supervision of junior Research Associates in analytical methods transfer, implementation, execution and documentation
- PhD in Analytical Chemistry, Biochemistry, Bioengineering or related field with 0-2 years relevant experience in Bioanalytics /Analytics
- Experience with in-line monitoring and integration of in-line probes with process control systems.
- Hands-on experience developing methods for in-process intermediates and final drug substances for bio-therapeutic antibody drugs.
- Experience with different modes of chromatography using LCMSMS and HPLC/UPLC interfaced with MALS, PDA, QDA, fluorescence, UV/VIS detectors.
- Experience in mass spectrometry multi-attribute measurement, including post translational modification of biologics products.
- Experience in a variety of computer software for acquiring and analyzing capillary electrophoresis, mass spectrometric, and chromatographic data (e.g, Empower, MassLynx, Open Lab, ChemStation, etc.).
- Knowledge in QbD, In-process controls and relationship between CQAs and analytical control strategy is highly desirable.
- Knowledge in critical quality assessments, point of control and structure-function related to key CQAâ€™s for biologic product.
- Well-organized, 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.
- Demonstrated ability for critical thinking, problem solving and innovation
Genzyme Corporation (a Sanofi company) 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.
Sanofi is a global healthcare leader focused on patients' needs, engaged in the research, development, manufacturing and marketing of therapeutic solutions focused on patientsâ€™ needs. Sanofi has core strengths in diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and Sanofi Genzyme.
At Sanofi, our ambition is to be an integrated global healthcare company, focused on patientsâ€™ needs. Much more than just a leading pharmaceutical company, Sanofi is committed to transforming scientific innovations into solutions and services that protect health, enhance life, and respond to the needs of the 7 billion people in the world. We trust our ambition to guide and inspire us as we work to create a future with optimal health and wellness for everyone.