Head of Analytical Sciences

About Sail Biomedicines:

Sail Biomedicines is harnessing evolutionary and artificial intelligence to revolutionize programmable medicines. Sail’s platform combines first-in-class programmable RNA technology (Endless RNATM or eRNA), and an industry-leading platform of programmable nanoparticles, utilizing natural components, to unlock comprehensive programming of medicines for the first time. By leveraging cutting-edge eRNA and nanoparticle deployment technology, Sail is building a wealth of data, enabling unparalleled use of AI techniques to identify and design fully programmable medicines that are potent, targeted, versatile, and tunable. Sail was founded by Flagship Pioneering.

The Role:

Reporting to the SVP of Technical Development and Operations, the Head of Analytical Sciences will be a key member of the R&D leadership team responsible for leading a cross-functional team of analytical/bioanalytical scientists developing and optimizing our innovative programable medicines. The ideal candidate will be a proven leader in analytical R&D directing method development and characterization testing to shape platform and product development strategies. . This is a unique opportunity to be a major contributor to the success of a well-positioned, pre-IPO growth stage biotechnology company.

Responsibilities

• Technical lead and department Head of analytical and bioassay method development and characterization for nucleic acids, antibody ligands, lipids, & lipid nanoparticles supporting platform, product, process, and formulations
• Develop methods that are fit-for-purpose to support the requirements of both early-stage development and progression into the clinic/GMP
• Use platform approaches & new technologies to effectively enhance the pipeline
• Develop high-throughput analytical methods in partnership with the Research team
• Lead development of analytical control strategies for drug substance, product and critical raw materials in partnership with the Development team
• Serve as analytical lead on product development and/or platform teams
• Lead the design and execution of comparability and stability studies
• Author/review method transfer, validation, data analysis & reporting for GMP & regulatory submissions
• Effectively collaborate with fully integrated CMC and development teams
• Manage and help grow a scientific team and demonstrate organizational leadership

Qualifications:

• PhD in chemistry or life sciences field with minimum 12+ years of industry experience in analytical sciences and development
• Broad leadership experience in nanoparticle-based delivery including natural and synthetic nanoparticles.
• Experience with RNA, lipid nanoparticles, and ligand targeting
• Deep knowledge of relevant analytical methods incl. biochemical, biophysical, bioanalytical, and cell-based. E.g. Fragment Analyzer, CE, LC/MS, PCR (qPCR, ddPCR), ELISA, SDS-PAGE, DLS, and cell-based assays
• Knowledge of GMP requirements
• Experience writing validation protocols / reports, relevant sections of regulatory documents
• Skilled in the discovery, optimization, and use of cell-based assays for mechanistic studies
• Analytical assay development
• Ability to solve complex problems in a fast-paced environment.
• Ability to work cross-functionally in a matrixed environment.
• Excellent verbal and written communication skills
• Strong people management skills with demonstrated ability to manage high performing interdisciplinary teams, mentor and coach scientists and promote career development.