Sanofi · 1 day ago
Purification Applications Leader
Framingham, MA
Full-time
Onsite
Senior Level, Lead/Staff
10+ years expSanofi is an innovative global healthcare company dedicated to improving people's lives. The Purification Applications Leader will provide technical leadership in downstream processing, focusing on chromatography and filtration performance, while collaborating with various teams to drive innovations and standardization across manufacturing operations.
Health CareLife SciencePharmaceuticalTherapeutics
Responsibilities
Represent MSAT as a DSP subject matter expert (chromatography and filtration) in various technical forums within the broad Sanofi network. Drive DSP operation standardization and best practice across platforms (Mammalian, Microbial, Vaccine). Serve as a core point of contact to support MSAT programs and global manufacturing sites, and to collaborate with R&D/CMC teams
Lead complex manufacturing investigation such as large column packing performance; pre-packed column quality, raw material (resin and filter) quality and performance, chromatography and filtration skid equipment cleaning/sanitization/storage, filter integrity test variation, bioburden and contamination control, Unit operation automation, and other scalability and manufacturability issues. Provide key technical guidance to manufacturing support teams by integrating knowledge from process, operation, equipment, and raw material
Responsible for DSP pilot operation design and practice. Work with MSAT pilot teams to establish the scale-up guidelines for various DSP operation. Draft training protocols for manufacturing staff at pilot facility. Work with MSAT and CMC pilot teams to drive the necessary pilot data package to evaluate facility fit and manufacturability. Lead pilot scale studies to drive investigation and process definition
Lead DSP innovations from conceptualization to implementation. Work with MSAT teams to design and implement innovations such as custom designed chromatography or filtration skid, continuous DSP configuration and PAT, custom fabricated resins, filters, absorbers, and fibers. Lead collaboration with Sanofi suppliers and external partners to enable preferred raw material supply with acceptable standards
Support other downstream unit operations such as centrifugation, viral inactivation, freezing/thawing, and protein stability. Support next generation process development, control strategy implementation, process validation, Tech Transfer, process comparability for global MSAT program launch at both Internal and external manufacturing sites
Support Quality and Regulatory during health authority inspection and prepare for supportive documents for new filings or responses. Lead internal report preparation to support various regulatory activities
Serve as a technical mentor to MSAT team members, provide training and supervision to project team members as needed. Participate in internal and external scientific exchanges to enhance MSAT competencies and reputation
Qualification
Required
Master or PhD degree in Biological/Biomedical, Sciences/Engineering
10+ years of experience related to biopharmaceutical industry. Minimum of 5 years of hands-on experience in downstream manufacturing support or field technical support from a major supplier
Process knowledge across multiple modalities (e.g. mAbs, small protein and peptide, bioconjugates, nucleotides, Gene/cell therapy, organic chemistry etc.)
Extensive knowledge with pilot and manufacturing scale chromatography and filtration equipment and operation
In-depth understanding of various chromatographic separation mechanisms including affinity, ion-exchange, Hydrophobic, and Mix-mode. In-depth understanding of different filtration fundamentals (TFF, sterile filtration, membrane and fiber applications) and different operation modes (single-pass, alternative pass, continuous, nominal and tangential)
Prior experience of managing contractor manufacturing or contract research partners
Excellent scientific background and effective communication skills. Demonstrated ability to manage and prioritize multiple projects and consistently meet deadlines
Highly motivated individual with the ability to work independently as well as within cross-functional and cross-site teams
Oral and written fluency in English
Benefits
High-quality healthcare
Prevention and wellness programs
At least 14 weeks’ gender-neutral parental leave
Company
Sanofi
Sanofi is a global biopharma company focused on prescription drugs, vaccines, and treatments for chronic, rare, and infectious diseases.
10001+ employees
H1B Sponsorship
Sanofi has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (101)
2024 (68)
2023 (59)
2022 (78)
2021 (38)
2020 (38)
Funding
Current Stage
Public CompanyTotal Funding
$6.97BKey Investors
Blackstone Life SciencesEvotec
2025-10-28Post Ipo Debt· $3B
2025-06-17Post Ipo Debt· $1.74B
2025-03-05Post Ipo Debt· $1.59B
Leadership Team
Paul Hudson
Chief Executive Officer
Francois-Xavier Roger
Chief Financial Officer
Recent News
2026-01-06
BioWorld Financial Watch
2026-01-06
2026-01-06
Company data provided by crunchbase