Purification Applications Leader

Overview

Job Title: Purification Applications Leader

Location:

Framingham, MA

About the Job:
We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.

Sanofi’s Global MSAT (Manufacturing Sciences, Analytics, and Technology) acts as a crucial link between our R&D and Manufacturing entities, playing an instrumental role in enhancing our current portfolio and delivering future launches of high-quality and innovative drugs and vaccines. Global MSAT is a beacon of innovation and process excellence in Manufacturing, this includes guiding the journey of new products from their launch to commercial success, being at the forefront of Data Sciences and Digitalization.

Join a team of talented and passionate international experts, scientists, and project leaders dedicated to inventing, designing, industrializing, and implementing cutting-edge industrial chemical and biological processes, analytical methods, and process modeling to successfully launch 3 to 5 new products by year.

The Principal Scientist in Downstream Process (DSP) will be part of the subject matter expert team and is responsible for providing technical leadership in monitoring and improving chromatography and filtration process performance at pilot and manufacturing scale.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

• 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 investigations 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 scale-up guidelines for various DSP operations. 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.

Qualifications/ Education & work experience

• 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,…