Sanofi Group Downstream Pilot Operations, Principal Development Associate in Framingham, Massachusetts
The Genomic Medicine Unit (GMU) Chemistry, Manufacturing and Control (CMC) group at Sanofi is dedicated to the establishment of best in class manufacturing platforms to support development of life-changing advanced cell and gene therapy products, including recombinant AAV vectors, non-viral vectors and cell therapy products. This organization encompasses vector and cell line engineering, upstream and downstream process development, analytics, and clinical manufacturing support.
The GMU purification process development group is responsible for the development of AAV viral vector processes and for supporting viral vector purification for next-generation production platforms to enable high-dose gene therapy programs. The Principal Research Associate role requires leadership both inside and outside the laboratory and will rely on industry expertise and the exploration of novel technologies in order to build robust and efficient purification processes consistent with patient safety standards.
We are looking for a candidate with experience in AAV purification development, scale-up, and pilot manufacturing, and technology transfer.
Lead the execution of large-scale manufacturing for downstream processing, from 50-L pilot through 2000-L scale to support pre-clinical manufacturing for ongoing CMC Projects.
Lead scale-up activities to implement a manufacturing process based on applied DSP knowledge.
Work directly with CMC project teams for logistical planning around manufacturing campaigns at pilot- and large-scale.
Lead the reviewing, revising, and authoring of SOPs, batch records, and batch reports for pilot and large-scale downstream manufacturing operations.
Perform data analyses related to the execution of pilot and large-scale DSP manufacturing, contribute to technical reports and internal/external presentations.
Lead troubleshooting experiments and communicate findings with appropriate working groups.
Maintain critical process equipment and pilot/large-scale downstream consumables to minimize downtime.
Lead and support the evaluation of new process technologies to increase product yield, reduce cost of goods and unit operation cycle times, and improve upon process understanding.
Lead and support ongoing digital transformation initiatives within the GMU CMC to enable the digitalization of manufacturing operations (e.g. electronic batch records/SOPs, process data capture, etc.).
Lead/support continuous process improvement initiatives to enhance downstream operational workflows.
Develop, maintain and demonstrate advanced knowledge of principals and techniques in column chromatography, filtration and other technologies.
Self-motivated and display sound technical judgement.
Mentor and support junior staff and build a culture of support and collaboration.
Communicate effectively with internal and external teams.
Master’s degree in chemical or biochemical engineering or related disciplines with a minimum of 2 years of relevant industry experience or a bachelor’s degree with a minimum of 4 years of relevant industry experience.
Significant experience of working with pilot and/or large-scale DSP manufacturing unit operations.
Significant experience, knowledge and understanding of purification technologies and operations such as:
Tangential flow filtration
Viral filtration and inactivation
Familiarity with advanced purification technologies.
Experience with process technology transfers and performing gap analyses and risk assessments.
Experience with digital solutions to enable efficient manufacturing operations (e.g. electronic batch records, electronic notebooks, etc.).
Expertise in drafting batch records, SOPs and technical reports.
Knowledge of basic analytical tools such as spectrophotometry, ELISA, HPLC, and SDS-PAGE and particle sizing.
Experience in AAV purification development.
Experience in CMC and drug development cycle.
Experience in writing CMC components of regulatory dossiers.
Knowledge of product comparability, target product profile and quality risk assessment activities.
Ability to work in Biosafety Level 2, follow safe lab procedures and maintain good laboratory practices (GLPs).
Ability to work under minimal supervision and function within a collaborative, team-oriented environment.
Excellent organization and communication skills.
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.
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.