COMPLETE Development Associate, Genomic Medicine Unit Purification Process Development Scale-Up Lab - Waltham, MA

Development Associate, Genomic Medicine Unit Purification Process Development Scale-Up Lab

Position Overview/Department Description       

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 viral, and 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 viral and non-viral vector processes and for supporting purification processes for next-generation production platforms to enable high-dose gene therapy programs. The Development Associate, Purification Process Development Scale-Up role requires self-motivation and a desire to learn both inside and outside the laboratory and will rely on industry expertise and the exploration of novel technologies to help build robust and efficient purification processes consistent with patient safety standards.

We are looking for a motivated candidate with good communication skills and a desire to learn purification process development and scale-up and contribute to organizational goals.

Key Responsibilities:

• Support 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

• Support scale-up activities to implement a manufacturing process based on DSP knowledge

• Work directly with CMC project teams for logistical planning around manufacturing campaigns at pilot- and large-scale

• Contribute to reviewing, revising, and authoring of SOPs, batch records, and batch reports for pilot and large-scale downstream manufacturing operations

• Support data analyses related to the execution of pilot and large-scale DSP manufacturing, contribute to technical reports and internal/external presentations

• Support troubleshooting experiments and communicate findings with appropriate working groups

• Maintain critical process equipment and pilot/large-scale downstream consumables to minimize downtime

• Support to evaluate new process and equipment technologies to increase product yield, reduce cost of goods and unit operation cycle times, and improve upon process understanding

• 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.)

• Support continuous process improvement initiatives to enhance downstream operational workflows

• Develop knowledge of principals and techniques in column chromatography, filtration and other process technologies, along with process data analytics

• Engage in and help to build a culture of support and collaboration among colleagues

• Communicate effectively with team and department members

Basic Qualifications

• Bachelor’s degree in biological science or engineering discipline

• Experience with working on pilot- and large-scale DSP manufacturing unit operations

• Demonstrates good organizational, record keeping skills and maintains safe work environment

• Experience in drafting batch records, SOPs and technical reports

Preferred Qualifications

• Familiarity with purification processes of viral vectors

• Knowledge of and experience with purification technologies and operations such as:

  • Depth filtration

  • Chromatography

  • Tangential flow filtration

  • Viral filtration and inactivation

• Ability to work in Biosafety Level 2, follow safe lab procedures and maintain good laboratory practices (GLPs)

• Knowledge of digital solutions to enable efficient manufacturing operations (e.g. electronic batch records, electronic notebooks, etc.)

• Motivated and self-directed with commitment to meet aggressive timelines

• Ability to work on multiple tasks simultaneously

• Self-motivated and display sound technical judgement

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

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.