About Sail: 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: Sail is seeking a creative and motivated Principal Engineer/Associate Director to develop scalable and efficient processes for Lipid Nanoparticle (LNP) manufacture. In this role, you will lead a Drug Product Process Development (DP PD) team and work cross functionally within the Technical Development & Operations department (Drug Substance Process Development, Analytical Sciences, Manufacturing Sciences, and Preclinical Manufacturing). You will also play a key role in representing the function as a Subject Matter Expert to the broader research organization and in advancing Sail's research programs to deliver novel eRNA based therapeutics to the clinic. We are searching for driven, enthusiastic and self-motivated individuals who are comfortable multitasking and working independently on various aspects of the platform. Responsibilities: * Define development strategies and design experimental plans to develop robust, efficient, and scalable manufacturing processes for Lipid Nanoparticles and LNP drug products at scales appropriate for preclinical testing and early clinical development * Lead the LNP process development team (in and outside the lab); provide mentorship and hands-on expert support in executing laboratory studies * Design and execute studies to characterize stability of LNP intermediates and drug products * Generate and analyze data to support data-driven decisions, establishment of process design space, identification of CQAs and CPPs * Collaborate with Platform on process transfers to DP PD * Collaborate with MS&T/Preclinical Manufacturing on process transfers out of DP PD, including process transfer to CDMOs * Collaborate with Analytical Sciences to characterize LNPs, related materials and processes * Serve as an SME representative on cross-functional Program Teams; manage and support Programs' demand for LNP scale-up * Maintain impeccable documentation for scientific data using electronic lab notebooks (ELNs) * Generate experimental protocols, development reports, and technology transfer packages; author CMC sections of Regulatory submissions Minimum qualifications: * M.S. or Ph.D. degree in an engineering, material science, or similar discipline * 6+ years (Ph.D.) or 12+ years (M.S.) of direct industry experience in process development of biologics and/or novel delivery systems * Expertise in LNP formulation processes, TFF operations, and related characterization methods * Expertise in statistical design of experiments (DoE), strong knowledge of Quality by Design (QbD) methodologies * Hands-on experience with defining and setting up equipment systems for LNP and TFF processes * Demonstrated ability of supervising/mentoring a technical team in a fast-paced environment, successfully advancing cross-functional projects, and building relationships across disciplines * Track record of independent problem-solving on highly complex challenges and scientific creativity * Experience with bioconjugation and targeted LNPs is a plus * Experience with authoring regulatory submissions is a plus * Experience with process transfers to CDMOs and GMP manufacturing is a plus * Experience with lyophilization process development is a plus * Experience with mRNA / circular RNA process development (IVT and purification) is a plus Sail Biomedicines is an Equal Opportunity Employer. Sail does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, national origin, veteran status, or any other status protected under federal, state, or local law.