Position Overview/Department Description
This position resides within the Genomic Medicine Unit (GMU), a part of Sanofi’s CMC Development organization. The GMU Analytical Development group has the overall responsibility to establish phase appropriate control strategies and to develop, qualify, and validate robust analytical methods to support release and characterization testing of different cell therapy candidates. The group supports cGMP-compliant in-process Quality Control (QC) support of cGMP Manufacturing cutting edge methods such as flow cytometry.
The selected candidate will execute rapid turnaround cGMP testing of in-process materials. In addition, contribute to method improvement, qualification, and drug product testing prior to going to clinical trials. The candidate will work with the team to facilitate these goals. This group will be in Framingham working onsite.
This position will be a rotating morning shift (9am-7pm), 4 days per week, and will be required to work two weekends a month.
Execute test methods following established procedures, compliant with cGMPs and in some cases turning data around in a rapid manner
Manage test deliverables and training activities to defined test schedules
Collaborate with colleagues to align on test requests
Maintain compliance of a cGMP environment ranging from instruments, to reagents, data packs, etc.
Manage analytical databases and perform data analysis to support assay performance and control
Contribute to assay investigations for out of expectation results or test failures
Lead or support internal assay transfers from analytical development teams
Write simple technical reports & SOPs, including clear and concise technical data presentation and discussion.
Generate of materials for internal/external presentations as needed
Participate in interdepartmental meetings and project specific sub-team meetings
Train on new approaches needed for incoming programs and act periodically as the lead to train colleagues.
Plan, prioritize and execute simple and complex experiments with the relevant controls with little guidance from their supervisor.
Acquire, compile, analyze, and interpret data with minimal supervision.
Work within a broader team to support the development and implementation of new ways of working and methodologies.
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 molecular biology techniques, cell culture and cellular based assay development
Experience using and developing molecular techniques such as residual, identity, and strength assays (including platforms ranging from flow cytometry, ELISAs, and cell counting).
A minimum of 1 year experience in a cGMP environment.
Experience validation and transfer analytical methods.
Experience using Quality by Design (QbD) principles and have used Design of Experiment (DOE) approaches for method development/optimization.
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.