Scientist, Downstream Process Scale-Up

Job Title: Scientist

• Location: Waltham, MA

About the Job:

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 and non-viral vectors. 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 Scientist 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 hands-on experience executing downstream purification at pilot and large scale, with a strong background in scale-up and some exposure to technology transfer. Experience across biologics modalities is valued, and experience with AAV or other viral vectors is a plus.

Join the engine of Sanofi’s mission — where deep immunoscience meets bold, AI-powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions.

About Sanofi:

We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.

Main Responsibilities:

• Lead the execution and scale-up of downstream purification manufacturing, from 50-L pilot through 2000-L scale, partnering with CMC project teams on logistical planning for pre-clinical manufacturing campaigns
• Lead the authoring, review, and revision of SOPs, batch records, and batch reports for pilot and large-scale downstream operations
• Perform data analyses supporting pilot and large-scale DSP manufacturing, and contribute to technical reports and internal/external presentations
• Lead troubleshooting of manufacturing issues and communicate findings to appropriate working groups
• Maintain critical process equipment and consumables to minimize downtime, and lead or support evaluation of new process technologies to improve yield, cost, and cycle times
• Support digital transformation and continuous improvement initiatives within GMU CMC (e.g., electronic batch records, process data capture, workflow enhancements)
• Develop and maintain advanced knowledge of column chromatography, filtration, and related purification technologies; mentor junior staff and foster a collaborative team culture

About You:

Education:

• Master’s degree in chemical or biochemical engineering or related disciplines with a minimum of 2 years of relevant experience or a bachelor’s degree with a minimum of 4 years of relevant experience

Experience & Technical Skills:

• Significant experience of working with pilot- and large-scale DSP manufacturing unit operations
• Significant experience, knowledge, and understanding of purification technologies and operations.

• Required: Hands-on experience with Chromatography and Tangential Flow Filtration (TFF)
• Preferred: Experience with Depth Filtration and/or Viral Filtration/Inactivation.

• Experience with process technology transfers and performing gap analyses and risk assessments
• Expertise in drafting batch records and SOPs (required); experience authoring technical reports (preferred).

Preferred Qualifications:

• Experience in AAV purification development
• Experience in CMC and drug development
• Experience with digital solutions to enable efficient manufacturing operations (e.g. electronic batch records, electronic notebooks, etc.). Knowledge of product comparability, target product profile and quality risk assessment activities
• Knowledge of basic analytical tools such as UV spectrophotometry and DLS particle sizing
• Ability to work in Biosafety Level 2, follow safe lab procedures and maintain good laboratory practices (GLPs)

Soft Skills:

• 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

Why choose us?

• Bring the miracles of science to life alongside a supportive, future focused team.
• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.

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