Scientist, Downstream Process Scale-Up

Sanofi • Waltham, MA

10h • Onsite

About The Position

The Scientist will work within Sanofi’s Genomic Medicine Unit (GMU) Chemistry, Manufacturing and Control (CMC) purification process development group. The group develops AAV viral vector processes and supports viral vector purification for next-generation production platforms and high-dose gene therapy programs. The role combines laboratory leadership, industry expertise, and exploration of novel technologies to develop robust, efficient purification processes consistent with patient safety standards.

The position focuses on hands-on downstream purification manufacturing and scale-up from 50-L pilot through 2000-L scale, with some exposure to technology transfer. Experience across biologics modalities is valued; AAV or other viral-vector experience is a plus. The Scientist will support manufacturing campaigns, process documentation, data analysis, troubleshooting, equipment readiness, technology evaluation, and digital transformation and continuous-improvement initiatives. The role also includes developing advanced purification-technology expertise, mentoring junior staff, and contributing to a collaborative team culture.

Requirements

• Master’s degree in chemical engineering, 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).
• 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 and within a collaborative, team-oriented environment.
• Excellent organizational and communication skills.
• Ability to communicate and represent the group in diverse, multifunctional meetings.

Nice To Haves

• Experience with depth filtration and/or viral filtration or inactivation.
• Experience with process technology transfers, gap analyses, and risk assessments.
• 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.
• Perform data analyses supporting 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, 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, 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, prevention, and wellness programs.
• At least 14 weeks of gender-neutral parental leave.
• Employee benefit programs; eligibility may apply.
• Rewards package recognizing employee contributions and impact.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level