Senior Scientist, GMU CMC Purification Process Development
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The Genomic Medicine Unit in Sanofi is responsible for the design and optimization of viral vector manufacturing processes and platforms. This organization encompasses vector and cell line engineering, upstream and downstream process development, analytics, and clinical manufacturing support.
The GM purification process development group is responsible for the development of AAV and lentiviral vectorpurificationprocessestosupportnext-generation production platforms to enable high-dose gene therapy programs. The Senior Scientist –PurificationProcess Development role requires leadership both inside and outside the laboratory and will rely on industry expertise and the exploration of novel technologies in order to build robust and efficient purification processes consistent withregulatory andpatient safety standards.
We are looking for a candidateexcellentin scientific orientationwithgood communication skills andindustryexperience in purification development, scale-up,manufacturing, and technology transfer.
Independently develop, design and conductviral vectorpurification experiments and evaluate new technologies to increase product yield and processunderstanding.
Develop, maintain and demonstrate advanced knowledge of principals and techniques in column chromatography and other areas of downstream purificationtechnology.
Maintain industry knowledge and awareness of new and relevant technologies, and be willing to publish/ patentfindings and to speak both internally and externally as industryleaders.
Lead development of study designusing DOE and HTPD tools, optimization of purification process conditions, media screeningand perform troubleshooting experiments,and communicate findings with appropriate workinggroups.
Perform data analyses, contribute to technical reports and internal/externalpresentations.
Lead scale-up activities to implement a manufacturing process based on applied DSPknowledge.
Communicate effectively with internal and external teams,e.g.CDMOs for tech transferactivities.
Contribute to manuscript and patent writing for externaland internalpublications,respectively.
This position is anindividualcontributorroleand do not have directreport .
Mentor and support junior staff and build a culture of support andcollaboration.
PhD degree in Biotechnology, Biochemistry, Chemical Engineering or related discipline with a minimum of 4 years of relevant experience or aMaster’sdegree with a minimum of 8 years of experience.
Industry experience ofpurification platformdevelopment.
Experience in CMC and drug development cycle.
Significant experience, knowledge and understanding of purification technologies and operations such as:
AKTA or automated protein purification chromatography
Tangential flow filtrationor UF/DF
Virus clearance and inactivation
Filtration unit operations at various scales
Familiarity withadvanced purification technologiesandviral vector purification
Experience with process technology transfers and performing gap analyses and riskassessments
Strong understanding of the principles of Quality by Design and ability to apply DOE to downstreamdevelopment.
Expertise in technical reportwriting.
Knowledge of basic analyticaland advancedanalyticaltools.
Experience writing CMC components of regulatorydossiers.
Knowledge of product comparability, target product profile and quality risk assessment activities.
Viral clearance study design and executionexperience.
Late-stage purification experience.
Experience with large-scale unit operations.
Excellent aptitude towards science and technology development.
Goodpublicationtrackrecorddemonstratingaptitude towards technologydevelopment.
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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