COMPLETE Senior Research Associate - Pilot Plant Operator - Waltham, MA

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, through the development and implementation of robust and safe manufacturing practices, capable of supporting program needs, that are aligned with Sanofi internal standards and evolving regulatory expectations

The manufacturing operations team is responsible for the safe and compliant execution of established manufacturing procedures to meet aggressive program deliverables. The team is responsible for “transfer-in” of manufacturing operations from development, as well as manufacturing of product to support internal program needs and external technology transfers for early and late-stage clinical gene therapy products. The Senior Research Associate will be responsible for executing upstream and operations under control of established manufacturing procedures and cross training of junior staff as needed.

KEY ACCOUNTABILITIES

• Independently execute established procedures with accountability to accuracy and control of operational performance with a strong focus on aseptic technique, biological control, process safety and documentation practices

• Adherence to production schedules to ensure commitment to meet aggressive timelines and deliverables

• Collaborate with process development to identify areas of improvement and identify suitable solutions for improved process performance and control, as needed

• Support incoming and outgoing process transfers consistent with internal and external transfer procedures, working closely with customers and end users

• Independently, manage personal training schedules as per established procedures and other group policies supporting process control and safe operations

• Support process investigations to address process excursions or out of expectation results, identifying root cause and corrective action plans and monitoring for correction

• Provide self-awareness and real time analysis of operations to anticipate potential unexpected process outcomes, working collaboratively with team to resolve or find suitable solutions  

• Perform process analyses, contribute to technical reports, protocols and internal/external presentations as needed

• Provide support on maintaining facility infrastructure and all process support activities

• Attendance at Gene Therapy Technical Operations at inter-departmental meetings and work streams as needed

• Stay updated on new, relevant technologies and published literature to drive innovation within the group

• Occasional weekend and holiday work to support ongoing lab activities

BASIC QUALIFICATIONS

• BS in biology or a related discipline with 2+ years of relevant experience or a MS in a related discipline

• Knowledge and practical experience in upstream manufacturing operations; including but not limited to adherent and suspension cell culture, cell count technologies, disposable bioreactors, depth filtration/clarification, ATF/TFF perfusion technologies

• Practical experience in aseptic technique in a variety of cell line maintenance techniques

• Relevant experience in troubleshooting process excursions, performing investigations and identifying appropriate solutions

PREFERRED QUALIFICATIONS

• Experience with Gene Therapy manufacturing platforms including cell banking, viral banking and drug substance generation

• Experience and knowledge of working with risk group 2 infectious materials

• Experience performing process transfers, either to external third party vendors or internal transfers from outside parties is a plus

• Experience in technical writing preferred

• Self-directed and motivated individual and commitment to meet aggressive timelines

• Excellent organization and written skills, committed to internal documentation practices

• Ability to work on multiple tasks simultaneously

• Able to work under moderate supervision and function within a collaborative/team oriented environment

• Assist fellow lab associates in providing a functional, safe working environment while maximizing laboratory efficiency

• Mentoring junior staff for training and understanding of process performance

• Ability to communicate and represent group in meetings

• cGMP experience or support a plus

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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