BioProcess Analytics Research Associate GMU CMC
Waltham, Massachusetts, Framingham, Massachusetts
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The Sanofi Genomic Medicine Unit CMC organization is responsible for the design and optimization of viral vector and cell therapy manufacturing processes and platforms. A key function of this group is to establish operational excellence in the manufacturing of Sanofi’s emerging portfolio of gene therapy products, supported by a diverse panel of analytical methods to provide process understanding and product characterization.
The BioProcess Analytics support group located in Waltham, MA is responsible for execution of analytical methods to support manufacturing and development activities, building process understanding, and supporting life cycle management from early to late stage clinical entry. The Research Associate (Analytical Technician) is responsible for executing test methods under control of established procedures. We are looking for a candidate that has experience in an analytical setting that can independently manage and execute their testing schedule supportive of genomic medicines process development. In addition, they should possess the skills to interpret and communicate their data with the appropriate development teams.
Execute test methods following established procedures.
Collaborate with bioanalytical development to establish individual training plans and schedules.
Manage testing and training deliverables against defined schedules.
Maintain all documentation and reports, including assay documentation, training folders and assay databases.
Contribute to assay investigations for out of expectation results or test failures, working with manager and customers on root cause analysis and mitigation strategies.
Lead or support assay transfers as part of a cross functional team.
Support maintenance of facility infrastructure and management of inventories for assay supplies, reagents, controls and standards.
Perform data analyses and contribute to technical reports, protocols and internal/external presentations.
Attendance at GMU and inter-departmental meetings and work streams as needed.
Potential for occasional weekend and holiday work to support ongoing lab activities.
BS in biological sciences or related discipline.
Experience in an analytical setting and executing assays relevant to cell and gene therapy.
Excellent organization and documentation skills, committed to internal documentation practices.
A minimum of one year of relevant experience in the life sciences, biotechnology or pharmaceutical industry.
Basic knowledge and practical experience in cellular, molecular and chemistry analytical methodologies, including but not limited to qPCR, ddPCR, HPLC, ITA, Potency assays, SDS PAGE, ELISA and others as applicable.
Practical experience in aseptic technique in a variety of cell line maintenance techniques is preferred.
Relevant knowledge of Gene Therapy analytics methods is preferred, especially methods used to characterize Adenovirus, Adeno-Associated Virus and Lentiviral vectors.
Experience with automation technology platforms is highly desired.
Experience and knowledge of working with biohazard infectious agents is preferred.
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.
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
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