Principal Research Associate, Process Analytics Development, Gene Therapy- Framingham/MA

Job description

Job Summary

The gene therapy development and manufacturing group in Sanofi is responsible for the design and optimization of viral vector manufacturing processes and platforms. A key function of this group is to establish operational excellence in the manufacturing of gene therapy materials and products, supported by a diverse panel of analytical methods to provide process understanding and product characterization.

The process analytical group is responsible for performing process investigations and developing methods to support process and product understanding for all current and future gene therapy manufacturing platforms. The group is also responsible for identifying analytical deficiencies and finding solutions for continuous improvement and control of gene therapy processes. The Principal Research Associate will be responsible for the planning and execution of experiments and projects to support the life cycle management of current analytical methodologies and the development of next-generation analytical platforms for continued advancement of the process monitoring and control strategies.

Key Accountabilities

·  Develop and manage individual projects and deliverables with accountability to accurate and precise execution of work plans, and commitment to program timelines
·  Work closely with external vendors and manager to suitably research and evaluate technology platforms for application and fit into current Gene Therapy analytical strategies, remaining current with relevant technologies and published literature, and finding solutions for unmet needs and known analytical gaps
·  Continue to adapt and develop automation capabilities into current analytical methods to improve throughput and performance, and reduce operator ergonomic risk
·  Independently perform data analyses, contribute to technical reports, protocols and internal/external presentations
·  Provide technical support for process or test failure investigations, as well as out of expectation results
·  Support outgoing assay transfers consistent with internal and external assay transfer procedures, working closely with customers and end users
·  Collaborate with manufacturing and development teams to identify analytical deficiencies and work together to identify relevant and meaningful solutions
·  Contribute to routine assay support to maintain group capacity as needed
·  Represent Gene Therapy Technical Operations at inter-departmental meetings and work streams
·  Develop, maintain and demonstrate advanced knowledge of principals and techniques in viral vector analytical methods
·  Occasional weekend and holiday work to support ongoing lab activities
·  Mentor and train team members as needed

Education / Experience

·  BS in biological sciences or related field with 4 to 6 years of relevant experience
·  Or MS in biological sciences with 2 to 4 years of relevant experience in the life sciences, biotechnology or pharmaceutical industry.

Technical skills & Competencies / Language

·  Extensive knowledge and practical experience in relevant viral vector analytical methodologies including cellular, molecular and chemistry analytical platforms
·  Demonstrated ability in developing, implementing and executing analytical methodologies to support process and product understanding for all phases of the manufacturing including cell line generation/selection, cell banking/viral banking and drug substance/drug product manufacturing
·  Relevant experience in Gene Therapy analytics focusing on characterization of viral vectors, including but not limited to qPCR/PCR, cell based infectious titer/potency assays, SDS PAGE/CE SDS, HPLC, ELISA, cell culture, aseptic technique and others as applicable
·  Relevant experience in actively scouting, technology sensing and integrating new analytical technologies for method life cycle management and/or creation of novel analytical solutions to address unmet needs
·  Experience in designing and establishing High Throughput (HT) automation work-flows, liquid handlers and screening platforms for improved performance, capacity and robustness of sample analysis
·  Relevant experience in troubleshooting process and analytical excursions, performing investigations and identifying appropriate solutions
·  Experience in applying statistical principles in experiment design and modeling, and analytical data interpretation and presentation is a plus
·  Experience and knowledge of working with risk group 2 infectious materials
·  Relevant Gene Therapy CMC regulatory understanding to appropriately apply guidance expectations into process and product control strategies is preferred
·  Experience in analytical method transfers, either to external third party vendors or internal transfers from outside parties is preferred

Behavioural Competencies

·  Innovative and critical thinker, unafraid to propose aggressive solutions to complex problems
·  Self-directed and motivated individual, with strong work ethic and commitment to project goals and aggressive program deliverables
·  Excellent time/project management skills and ability to work on multiple projects simultaneously
·  Able to work under minimal supervision and function within a collaborative/team oriented environment
·  Assist fellow lab associates in providing a functional, safe working environment while maximizing laboratory efficiency
·  Excellent organization and written skills, committed to internal documentation practices
·  Ability to communicate and represent group in diverse, multi-functional meetings

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.