Scientist, Downstream Process Scale-Up
About The Position
The Genomic Medicine Unit (GMU) Chemistry, Manufacturing and Control (CMC) group at Sanofi develops manufacturing platforms for advanced cell and gene therapy products, including recombinant AAV and non-viral vectors. The GMU purification process development group develops AAV viral vector processes and supports purification for next-generation production platforms and high-dose gene therapy programs. The Scientist leads work inside and outside the laboratory, applying industry expertise and exploring new technologies to build robust, efficient purification processes that meet patient safety standards. The role focuses on hands-on downstream purification execution and scale-up from pilot to large scale, with some exposure to technology transfer. It partners with CMC project teams on pre-clinical manufacturing campaigns and supports process improvement, digital transformation, and continuous improvement initiatives. The position is based in Waltham, Massachusetts.
Requirements
- Master’s degree in chemical or biochemical engineering or a related discipline and at least 2 years of relevant experience, or a bachelor’s degree and at least 4 years of relevant experience.
- Significant experience working with pilot- and large-scale DSP manufacturing unit operations.
- Significant experience, knowledge, and understanding of purification technologies and operations.
- Hands-on experience with chromatography and tangential flow filtration (TFF).
- Experience with process technology transfers, gap analyses, and risk assessments.
- Expertise drafting batch records and SOPs.
- Ability to work in Biosafety Level 2, follow safe laboratory procedures, and maintain good laboratory practices (GLPs).
- Ability to work under minimal supervision in a collaborative, team-oriented environment.
- Excellent organization and communication skills.
- Ability to represent the group and communicate in diverse, multifunctional meetings.
Nice To Haves
- Experience with depth filtration and/or viral filtration or inactivation.
- Experience authoring technical reports.
- Experience in AAV purification development.
- Experience in CMC and drug development.
- Experience with digital solutions for efficient manufacturing operations, such as electronic batch records or electronic notebooks.
- 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.
- Experience across biologics modalities; AAV or other viral vector experience is a plus.
Responsibilities
- Lead 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.
- Analyze data from pilot and large-scale DSP manufacturing and contribute to technical reports and internal and external presentations.
- Lead troubleshooting of manufacturing issues and communicate findings to appropriate working groups.
- Maintain critical process equipment and consumables to minimize downtime.
- Lead or support evaluation of process technologies to improve yield, cost, and cycle times.
- Support digital transformation and continuous improvement initiatives within GMU CMC, including electronic batch records, process data capture, and workflow enhancements.
- Develop and maintain advanced knowledge of column chromatography, filtration, and related purification technologies.
- Mentor junior staff and foster a collaborative team culture.
Benefits
- Health and wellbeing benefits, including high-quality healthcare and prevention and wellness programs.
- At least 14 weeks of gender-neutral parental leave.
- Company employee benefit programs; further details are available through the company benefits information.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
