Bioprocess Analytical Scientist
The Genomic Medicine Unit (GMU) operates with the mission to develop robust, scalable, cost effective, and innovative cell and viral vector manufacturing processes and platforms. The BioProcess Analytics group is responsible for developing and executing a range molecular, biochemical and immunological methods to support our process development and manufacturing operation teams for current and future cell and gene therapy manufacturing platforms. The BioProcess Analytics group located in Waltham, MA, is seeking an experienced analytical Scientist to join our team of talented individuals. The successful candidate must have hands on experience in developing analytical methods with proven capabilities to independently manage projects. Scientific knowledge in cell and gene therapy analytics, is preferred. The candidate must be self-driven, independent, collaborative, and able to communicate effectively with a cross-functional team.
·Responsible for independently performing experiments to support the development ofa wide array of molecular and bioassays like qPCR, ddPCR, ELISA, potency and virus infectivity (TCID50) assays related to AAV and other non-viral gene therapy platforms.
·Design (DOE), plan, and execute method development experiments and perform deep data dives.
·Manage individual development plans and, lead the development of study design, optimization and qualification of analytical methods.
·Troubleshoot experiments and OOS results and, communicate findings to appropriate working groups.
·Evaluate new technologies to complement and enhance current analytical capabilities, with a focus on automation and high throughput needs.
·Work closely with process development and manufacturing to identify analytical deficiencies and propose relevant and meaningful solutions for enhanced process understanding and control.
·Write protocols and operating procedures, author and/or contribute to technical reports.
·Perform method specific safety risk assessments and write Job Safety Assessment to establish suitable HSE controls.
·Represent group at inter-departmental meetings, work streams and conferences.
·Mentor and support junior staff and build a culture of support and collaboration.
·PhD in biological sciences or Master’s degree with a minimum of 4 years of relevant industry experience or a Bachelor’s degree with a minimum of 8 years of relevant industry experience.
·Relevant demonstrated experience and knowledge of different developing analytical methods that includes molecular assays, cell-based and biochemical/immunological assays.
·Highly motivated, self-driven and must be able to work in a team-oriented environment
·Demonstrate attention to detail and good record-keeping.
·Excellent organizational and communication skills and, able to work in a fast-paced environment.
·Experience using QbD principles and tools e.g. DOE to develop analytical methods.
·Experience with automated analytical technology platforms for high throughput testing.
·Experience with gene therapy regulatory guidance’s, specific to cell and gene therapy products.
·Experience in developing and implementing novel methods to improve process and product understanding.
Special Working Conditions:
Required to work in a Biosafety Level 2 environment, that may include large scale operations support (LS-BL2).
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.