Purification Applications Leader

Role Summary

Purification Applications Leader

Location

Framingham, MA

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.

Qualifications

• 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