COMPLETE Senior Research Associate, Genomic Medicine Bioanalytics – Cell Therapy - Waltham, MA

Job Title: Senior Research Associate, Genomic Medicine Bioanalytics – Cell Therapy

Position Overview/Department Description

The Sanofi Genetic Medicine Unit CMC organization is responsible for the design and optimization of gene 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 cellular therapy products. The bioanalytical group provides analytical testing to support in-process, release, and stability testing, as well as development activities for process optimization and life cycle management from early- to late-stage clinical entry. 

The Senior Research Associate is responsible for execution of molecular biology and cell-based analytical test methods relevant to Sanofi Cell Therapy products. Additional functions will include interpretation of data, preparation of test documentation, and management of analytical databases.  We are looking for a candidate that is capable of learning quickly with the goal of executing analytical methods, with excellent communication skills.  The position is primarily located in Waltham, MA.

Responsibilities

• Develop, qualify, and transfer analytical methods (flow-based assays, ELISA assays, PCR assays, cell-based assays, etc) to support drug product release and characterization testing.

• Execute GMP test methods following established procedures

• Lead or support internal assay transfers to downstream QC applications

• Author method protocols, and contribute to technical reports/memos

• Participate in interdepartmental meetings and project-specific sub-team meetings

• Collaborate with colleagues to align on test requests

• Maintain compliance to test documentation completion and archiving

• Maintain analytical infrastructure and supply/reagent inventories

• Contribute to investigations for out-of-expectation results or test failures

• Perform regularly scheduled monthly instrument maintenance

Basic Qualifications

• Master’s degree in Biology/Biochemistry or related discipline or Bachelor’s degree with a minimum of two years of relevant experience in the Biotechnology/pharmaceutical industry.

• Experience with cell and molecular biology techniques (examples: aseptic tissue culture practices, PCR, ELISA, etc)

• Excellent organization and documentation skills, and communication skills

Preferred Qualifications

• 1 – 3 years of relevant experience in the life sciences, biotechnology, or pharmaceutical industry. Practical experience in aseptic technique in a variety of cell line maintenance techniques is preferred.

• Basic knowledge and practical experience in cellular, molecular and chemistry analytical methodologies, including but not limited to flow cytometry, qPCR, ELISA, cell-based assays and others as applicable

• Experience and knowledge of working with biohazardous biological material

• Experience with automation technology platforms is desired

• Experience and knowledge of working with biohazard infectious agents is preferred

• cGMP experience

• Relevant knowledge of Cellular Therapy analytics methods is preferred, especially methods used to characterize cells by immunophenotypic markers, identity and purity assays

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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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.